Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02964416
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2016-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
Sponsor:
Organization:
Raw JSON
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After treatment with desmopressin for Diabetes insipidus patient recovered and was extubated in ICU within 48 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'low conscious levels in post operative period', 'notes': 'One patient had a GCS of 8 after extubation and was shifted to ICU after getting reintubated. Reason was diabetes insipidus which was treated with Desmopressin.GCS improved later and the patient was extubated in 48 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Placebo'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Haemodynamic Parameters at the Time of Emergence and Postextubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '128.55', 'spread': '21.56', 'groupId': 'OG000'}, {'value': '132.34', 'spread': '22.38', 'groupId': 'OG001'}]}]}, {'title': '1min Before Extubation', 'categories': [{'measurements': [{'value': '132.63', 'spread': '22.12', 'groupId': 'OG000'}, {'value': '134.29', 'spread': '24.40', 'groupId': 'OG001'}]}]}, {'title': '1min After Extubation', 'categories': [{'measurements': [{'value': '141.81', 'spread': '23.15', 'groupId': 'OG000'}, {'value': '143.70', 'spread': '22.97', 'groupId': 'OG001'}]}]}, {'title': '2 min', 'categories': [{'measurements': [{'value': '134.89', 'spread': '21.57', 'groupId': 'OG000'}, {'value': '139.77', 'spread': '22.28', 'groupId': 'OG001'}]}]}, {'title': '5min', 'categories': [{'measurements': [{'value': '130.05', 'spread': '20.06', 'groupId': 'OG000'}, {'value': '133.37', 'spread': '21.08', 'groupId': 'OG001'}]}]}, {'title': '10min', 'categories': [{'measurements': [{'value': '126.95', 'spread': '17.26', 'groupId': 'OG000'}, {'value': '131.59', 'spread': '17.35', 'groupId': 'OG001'}]}]}, {'title': '20min', 'categories': [{'measurements': [{'value': '127.86', 'spread': '14.56', 'groupId': 'OG000'}, {'value': '133.15', 'spread': '15.68', 'groupId': 'OG001'}]}]}, {'title': '30min', 'categories': [{'measurements': [{'value': '127.19', 'spread': '16.29', 'groupId': 'OG000'}, {'value': '132.10', 'spread': '17.05', 'groupId': 'OG001'}]}]}, {'title': '1h', 'categories': [{'measurements': [{'value': '128.11', 'spread': '14.47', 'groupId': 'OG000'}, {'value': '129.80', 'spread': '16.51', 'groupId': 'OG001'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '127.76', 'spread': '16.21', 'groupId': 'OG000'}, {'value': '125.74', 'spread': '13.30', 'groupId': 'OG001'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '127.35', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '125.81', 'spread': '12.58', 'groupId': 'OG001'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '122.97', 'spread': '14.18', 'groupId': 'OG000'}, {'value': '122.61', 'spread': '17.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Systolic BP from the time of extubation till 6 hours post operatively', 'description': 'Systolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Haemodynamic Parameters at the Time of Emergence and Postextubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '82.26', 'spread': '12.77', 'groupId': 'OG000'}, {'value': '79.37', 'spread': '16.93', 'groupId': 'OG001'}]}]}, {'title': '1min Before Extubation', 'categories': [{'measurements': [{'value': '89.30', 'spread': '14.50', 'groupId': 'OG000'}, {'value': '91.41', 'spread': '16.96', 'groupId': 'OG001'}]}]}, {'title': '1min After Extubation', 'categories': [{'measurements': [{'value': '93.61', 'spread': '15.39', 'groupId': 'OG000'}, {'value': '98.54', 'spread': '19.81', 'groupId': 'OG001'}]}]}, {'title': '2 min', 'categories': [{'measurements': [{'value': '89.61', 'spread': '16.71', 'groupId': 'OG000'}, {'value': '93.50', 'spread': '17.46', 'groupId': 'OG001'}]}]}, {'title': '5min', 'categories': [{'measurements': [{'value': '86.27', 'spread': '15.77', 'groupId': 'OG000'}, {'value': '90.00', 'spread': '17.40', 'groupId': 'OG001'}]}]}, {'title': '10min', 'categories': [{'measurements': [{'value': '86.26', 'spread': '16.59', 'groupId': 'OG000'}, {'value': '86.70', 'spread': '16.76', 'groupId': 'OG001'}]}]}, {'title': '20min', 'categories': [{'measurements': [{'value': '82.44', 'spread': '16.18', 'groupId': 'OG000'}, {'value': '83.38', 'spread': '15.20', 'groupId': 'OG001'}]}]}, {'title': '30min', 'categories': [{'measurements': [{'value': '81.92', 'spread': '14.19', 'groupId': 'OG000'}, {'value': '84.10', 'spread': '14.95', 'groupId': 'OG001'}]}]}, {'title': '1h', 'categories': [{'measurements': [{'value': '79.53', 'spread': '13.34', 'groupId': 'OG000'}, {'value': '82.46', 'spread': '13.52', 'groupId': 'OG001'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '80.03', 'spread': '13.40', 'groupId': 'OG000'}, {'value': '81.97', 'spread': '14.90', 'groupId': 'OG001'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '78.94', 'spread': '13.20', 'groupId': 'OG000'}, {'value': '81.23', 'spread': '16.58', 'groupId': 'OG001'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '79.65', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '78.20', 'spread': '15.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'HR from the time of extubation till 6 hours post operatively', 'description': 'Heart rate will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If haemodynamic values of heart rate rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Haemodynamic Parameters at the Time of Emergence and Postextubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'Base line', 'categories': [{'measurements': [{'value': '75.92', 'spread': '11.48', 'groupId': 'OG000'}, {'value': '77.83', 'spread': '12.93', 'groupId': 'OG001'}]}]}, {'title': '1min Before Extubation', 'categories': [{'measurements': [{'value': '77.30', 'spread': '11.96', 'groupId': 'OG000'}, {'value': '78.65', 'spread': '12.63', 'groupId': 'OG001'}]}]}, {'title': '1min After Extubation', 'categories': [{'measurements': [{'value': '83.97', 'spread': '10.69', 'groupId': 'OG000'}, {'value': '85.78', 'spread': '13.59', 'groupId': 'OG001'}]}]}, {'title': '2 min', 'categories': [{'measurements': [{'value': '79.19', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '82.41', 'spread': '12.32', 'groupId': 'OG001'}]}]}, {'title': '5min', 'categories': [{'measurements': [{'value': '78.68', 'spread': '10.63', 'groupId': 'OG000'}, {'value': '78.59', 'spread': '10.09', 'groupId': 'OG001'}]}]}, {'title': '10min', 'categories': [{'measurements': [{'value': '77.37', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '78.32', 'spread': '8.43', 'groupId': 'OG001'}]}]}, {'title': '20min', 'categories': [{'measurements': [{'value': '78.19', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '76.73', 'spread': '9.77', 'groupId': 'OG001'}]}]}, {'title': '30min', 'categories': [{'measurements': [{'value': '77.14', 'spread': '9.67', 'groupId': 'OG000'}, {'value': '76.93', 'spread': '9.37', 'groupId': 'OG001'}]}]}, {'title': '1h', 'categories': [{'measurements': [{'value': '76.39', 'spread': '8.90', 'groupId': 'OG000'}, {'value': '75.33', 'spread': '8.64', 'groupId': 'OG001'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '75.71', 'spread': '11.07', 'groupId': 'OG000'}, {'value': '75.89', 'spread': '8.87', 'groupId': 'OG001'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '74.85', 'spread': '9.96', 'groupId': 'OG000'}, {'value': '78.00', 'spread': '11.96', 'groupId': 'OG001'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '75.26', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '74.89', 'spread': '11.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Diastolic BP from the time of extubation till 6 hours post operatively', 'description': 'Diastolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'At resumption of spontaneous breathing', 'categories': [{'title': 'Poor extubation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked coughing or straining', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Moderate coughing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very smooth minimal coughing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No coughing or straining', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Ability to respond to verbal commands', 'categories': [{'title': 'Poor extubation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked coughing or straining', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate coughing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Very smooth minimal coughing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No coughing or straining', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'At cuff deflation', 'categories': [{'title': 'Poor extubation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked coughing or straining', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate coughing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Very smooth minimal coughing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'No coughing or straining', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'At extubation', 'categories': [{'title': 'Poor extubation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked coughing or straining', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Moderate coughing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Very smooth minimal coughing', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'No coughing or straining', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': '2 minutes after extubation', 'categories': [{'title': 'Poor extubation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Marked coughing or straining', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Moderate coughing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Very smooth minimal coughing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No coughing or straining', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cough at the time of emergence', 'description': 'Cough will be described on following scale 5 = No coughing or straining, 4 = Very smooth minimal coughing, 3 = Moderate coughing, 2 = Marked coughing or straining,\n\n1 = Poor extubation\n\nCough will be recorded on the above mentioned scale by resident/consultant at following time intervals of emergence\n\n* At resumption of spontaneous breathing,\n* Ability to respond to verbal commands\n* At cuff deflation\n* At extubation\n* 2 minutes after extubation. It will be noted if it occurs during emergence at the above mentioned time intervals. Absence of it will be considered as smooth emergence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the time of extubation till 6 hours postoperatively', 'description': 'If there is any episode of bronchospasm or laryngospasm, it will be noted if it occured during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence', 'unitOfMeasure': 'Number of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Laryngospasm and Bronchospasm and breath holding did not occur, therefore not shown there.'}, {'type': 'SECONDARY', 'title': 'Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'timeFrame': 'at the time of extubation till 6 hours postoperatively', 'description': 'If there is any episode of sedation it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence.\n\nsedation score will be used as 0= no sedation, 1= mildly sedated (eye opening on verbal commands), 2= moderately sedated ( awakens on giving pain), 3= deeply sedated ( not waking up even on pain)', 'reportingStatus': 'POSTED', 'populationDescription': 'The data was inconsistent and was not reported adequately in the questionnaire.'}, {'type': 'SECONDARY', 'title': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'Recovery Room', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Recovery Room , 2, 4 and 6 hours postoperatively', 'description': 'Post operative nausea vomiting will be recorded at RR, 2, 4 and 6 hours postoperatively. If there is any episode of PONV it will be noted. Absence of it will be considered as smooth emergence', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'Recovery Room', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Recovery Room, 2, 4 and 6 hours postoperatively', 'description': 'Convulsions will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively.If there is any episode of convulsion, it will be noted. Absence of it will be considered as smooth emergence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'Recovery Room : <8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Recovery Room : 9-12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Recovery Room : 13-15', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': '2h : <8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2h : 9-12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2h : 13-15', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': '4h : <8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '4h : 9-12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '4h : 13-15', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': '6h : <8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '6h : 9-12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6h : 13-15', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at Recovery Room, 2, 4 and 6 hours postoperatively', 'description': 'Post operative Glasgow Coma Scale (GCS) will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively. If there is any deterioration in GCS less than 8/15, Patients will be intubated.\n\nGCS categories \\<8 Low GCS 9-12 Intermediate GCS 13-15 Full GCS', 'unitOfMeasure': 'Number of Patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'Recovery Room', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '2h', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '4h', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '6h', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Recovery room, 2, 4 and 6 hours postoperatively', 'description': 'Requirement of analgesia will be recorded at recovery room, 2, 4 and 6 hours postoperatively. If there is any need of analgesic, it will be noted and will be considered as one of the determinants of poor quality of emergence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg once at the time of dura closure'}, {'id': 'OG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}], 'classes': [{'title': 'at resumption of spontaneous breathing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'at the time of obeying of verbal commands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'at the time of cuff deflation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'at the time of extubation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '2 min after extubation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the time of extubation', 'description': 'If there is any episodes of denaturation (Oxygen saturation \\<92%), it will be noted it it is occurring during emergence.\n\nAbsence of it will be considered as smooth emergence', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure\n\nInjection Tramadol'}, {'id': 'FG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure\n\nplacebo: 0.9% Normal saline in 10 ml syringe'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Over a period of two years, 2016 and 2017\n\nPatients were recruited in the study during the preoperative anesthesia evaluation either at the preoperative clinic or from the ward after admission.', 'preAssignmentDetails': 'A total of 80 patients were enrolled and selected to randomize. 39 patients in Tramadol group and 41 patients in placebo group.79 patients completed the study as one patient in tramadol group dropped out due to change/ modification in his surgical procedure.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure'}, {'id': 'BG001', 'title': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.42', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '44.7', 'spread': '14.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '00', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Pakistan', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '4.80', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '4.88', 'groupId': 'BG001'}, {'value': '26.7', 'spread': '4.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-05', 'size': 145664, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-21T05:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2016-09-19', 'resultsFirstSubmitDate': '2019-07-28', 'studyFirstSubmitQcDate': '2016-11-11', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-21', 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemodynamic Parameters at the Time of Emergence and Postextubation', 'timeFrame': 'Systolic BP from the time of extubation till 6 hours post operatively', 'description': 'Systolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.'}, {'measure': 'Haemodynamic Parameters at the Time of Emergence and Postextubation', 'timeFrame': 'HR from the time of extubation till 6 hours post operatively', 'description': 'Heart rate will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If haemodynamic values of heart rate rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.'}, {'measure': 'Haemodynamic Parameters at the Time of Emergence and Postextubation', 'timeFrame': 'Diastolic BP from the time of extubation till 6 hours post operatively', 'description': 'Diastolic blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.'}], 'secondaryOutcomes': [{'measure': 'Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.', 'timeFrame': 'Cough at the time of emergence', 'description': 'Cough will be described on following scale 5 = No coughing or straining, 4 = Very smooth minimal coughing, 3 = Moderate coughing, 2 = Marked coughing or straining,\n\n1 = Poor extubation\n\nCough will be recorded on the above mentioned scale by resident/consultant at following time intervals of emergence\n\n* At resumption of spontaneous breathing,\n* Ability to respond to verbal commands\n* At cuff deflation\n* At extubation\n* 2 minutes after extubation. It will be noted if it occurs during emergence at the above mentioned time intervals. Absence of it will be considered as smooth emergence.'}, {'measure': 'Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.', 'timeFrame': 'at the time of extubation till 6 hours postoperatively', 'description': 'If there is any episode of bronchospasm or laryngospasm, it will be noted if it occured during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence'}, {'measure': 'Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score', 'timeFrame': 'at the time of extubation till 6 hours postoperatively', 'description': 'If there is any episode of sedation it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence.\n\nsedation score will be used as 0= no sedation, 1= mildly sedated (eye opening on verbal commands), 2= moderately sedated ( awakens on giving pain), 3= deeply sedated ( not waking up even on pain)'}, {'measure': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV', 'timeFrame': 'at Recovery Room , 2, 4 and 6 hours postoperatively', 'description': 'Post operative nausea vomiting will be recorded at RR, 2, 4 and 6 hours postoperatively. If there is any episode of PONV it will be noted. Absence of it will be considered as smooth emergence'}, {'measure': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions', 'timeFrame': 'at Recovery Room, 2, 4 and 6 hours postoperatively', 'description': 'Convulsions will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively.If there is any episode of convulsion, it will be noted. Absence of it will be considered as smooth emergence.'}, {'measure': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS', 'timeFrame': 'at Recovery Room, 2, 4 and 6 hours postoperatively', 'description': 'Post operative Glasgow Coma Scale (GCS) will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively. If there is any deterioration in GCS less than 8/15, Patients will be intubated.\n\nGCS categories \\<8 Low GCS 9-12 Intermediate GCS 13-15 Full GCS'}, {'measure': 'Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia', 'timeFrame': 'At Recovery room, 2, 4 and 6 hours postoperatively', 'description': 'Requirement of analgesia will be recorded at recovery room, 2, 4 and 6 hours postoperatively. If there is any need of analgesic, it will be noted and will be considered as one of the determinants of poor quality of emergence.'}, {'measure': 'Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation', 'timeFrame': 'at the time of extubation', 'description': 'If there is any episodes of denaturation (Oxygen saturation \\<92%), it will be noted it it is occurring during emergence.\n\nAbsence of it will be considered as smooth emergence'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['supratentorial craniotomy', 'extubation response', 'emergence', 'tramadol'], 'conditions': ['Brain Neoplasm']}, 'referencesModule': {'references': [{'pmid': '8638792', 'type': 'BACKGROUND', 'citation': 'Mikawa K, Nishina K, Maekawa N, Obara H. Attenuation of cardiovascular responses to tracheal extubation: verapamil versus diltiazem. Anesth Analg. 1996 Jun;82(6):1205-10. doi: 10.1097/00000539-199606000-00018.'}, {'pmid': '22089326', 'type': 'BACKGROUND', 'citation': 'Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.'}, {'pmid': '10195515', 'type': 'BACKGROUND', 'citation': 'Valley RD, Ramza JT, Calhoun P, Freid EB, Bailey AG, Kopp VJ, Georges LS. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of isoflurane and sevoflurane. Anesth Analg. 1999 Apr;88(4):742-5. doi: 10.1097/00000539-199904000-00010.'}, {'pmid': '8024135', 'type': 'BACKGROUND', 'citation': 'Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013.'}, {'pmid': '11452859', 'type': 'BACKGROUND', 'citation': 'Ferber J, Juniewicz H, Glogowska E, Wronski J, Abraszko R, Mierzwa J. Tramadol for postoperative analgesia in intracranial surgery. Its effect on ICP and CPP. Neurol Neurochir Pol. 2000;34(6 Suppl):70-9.'}, {'pmid': '17506732', 'type': 'BACKGROUND', 'citation': 'Sudheer PS, Logan SW, Terblanche C, Ateleanu B, Hall JE. Comparison of the analgesic efficacy and respiratory effects of morphine, tramadol and codeine after craniotomy. Anaesthesia. 2007 Jun;62(6):555-60. doi: 10.1111/j.1365-2044.2007.05038.x.'}, {'pmid': '19630495', 'type': 'BACKGROUND', 'citation': 'Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.'}, {'pmid': '10235420', 'type': 'BACKGROUND', 'citation': 'Lintz W, Beier H, Gerloff J. Bioavailability of tramadol after i.m. injection in comparison to i.v. infusion. Int J Clin Pharmacol Ther. 1999 Apr;37(4):175-83.'}, {'pmid': '37013278', 'type': 'DERIVED', 'citation': 'Salam AA, Rehman A, Shamim MS, Khan FA. Effect of tramadol on extubation response and quality of emergence following Supratentorial surgery: A randomised controlled trial. J Pak Med Assoc. 2022 Nov;72(11):2160-2165. doi: 10.47391/JPMA.4082.'}]}, 'descriptionModule': {'briefSummary': 'Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care. The advantages of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelet makes it a safe medication to use for neurosurgical patients after craniotomy. The primary objective of the study is to observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic response (measurement of B.P and H.R) during extubation.', 'detailedDescription': 'Extubation after intracranial tumor surgery is desirable in order to make an early diagnosis of intracranial complications. Extubation however, may be associated with haemodynamic and metabolic changes e.g. agitation, increased oxygen consumption, catecholamine secretion, hypercapnia and systemic hypertension.\n\nThese changes cause cerebral hyperemia, intracranial hypertension leading to cerebral oedema or haemorrhage, thus it is important to have smooth extubation with minimal haemodynamic and metabolic effects.\n\nIncidence of coughing on emergence from general anesthesia ranges from 38% to 96%. This may also result in postoperative intracranial hemorrhage, intracranial hypertension, cerebral edema or intraocular hypertension.This can be detrimental in neurosurgery.\n\nSeveral modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care.\n\nTramadol, a synthetic opioid of the aminocyclohexanes group, is a centrally acting opioid analgesic that is used to treat moderate-to-severe pain and has an inhibitory effect on M1 and M3 muscarinic receptors. It also reduces the incidence of cough and improves extubation quality, and provides more stable haemodynamics during emergence. It neither causes respiratory depression, nor affects intracranial pressure (ICP) and cerebral perfusion pressure (CPP). Other potential advantage of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelets thus making it a safe medication to use for neurosurgical patients after craniotomy. The onset of effect following a single dose is 3 to 5 minutes with peak effect at 45 minutes.\n\nAim of doing this study is to observe the effect of a single dose of tramadol on quality of tracheal extubation as judged by incidence of coughing and haemodynamic changes at emergence from anesthesia.\n\nOBJECTIVE:\n\nPrimary Objective: To observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on haemodynamic response (measurement of B.P and H.R) during extubation.\n\nSecondary Objective: To measure the quality of emergence from general anaesthesia by measuring the frequency of cough, laryngospasm and episodes of desaturation.\n\nOPERATIONAL DEFINITION:\n\nEmergence Period: This will be defined as the time from the recovery of spontaneous breathing after giving reversal to tracheal extubation.\n\nQuality of emergence: Good quality emergence will be defined as extubation not associated with coughing, bucking, tachycardia, hypertension, laryngospasm or bronchospasm.\n\nTachycardia and hypertension: Rise in heart rate and blood pressure more than 20% from baseline value.\n\nExtubation response: Physiological response related to blood pressure and heart rate during extubation of trachea is called extubation response,\n\nHYPOTHESIS:\n\nTramadol obtunds haemodynamic and cough response to extubation and thus results in good quality emergence after supratentorial craniotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with craniotomy for supratentorial tumors under general anesthesia\n* American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients\n* Elective surgery\n* Patients with Glasgow Coma Scale (GCS) 15/15\n\nExclusion Criteria:\n\n* Patients with a history of allergy or hypersensitivity to tramadol.\n* History of epilepsy or convulsions due to any reason.\n* Chronic usage of analgesic drugs.\n* Patients using monoamine oxidase inhibitors.\n* Patients with clinical signs of raised ICP.\n* Obesity (women with a body mass index \\>35 kg/m2 or men with a body mass index \\>42 kg/m2)\n* Language barrier.\n* Patients taking B-blockers or Ca channel blockers.\n* Patients above 65 years of age ( Physiology difference)'}, 'identificationModule': {'nctId': 'NCT02964416', 'briefTitle': 'Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery', 'orgStudyIdInfo': {'id': '2954-Ane-ERC-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tramadol', 'description': 'Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure', 'interventionNames': ['Drug: Injection Tramadol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Injection Tramadol', 'type': 'DRUG', 'otherNames': ['Tramal'], 'armGroupLabels': ['Tramadol']}, {'name': 'placebo', 'type': 'OTHER', 'otherNames': ['normal saline'], 'description': '0.9% Normal saline in 10 ml syringe', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Asma A Salam, MCPS, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Instructor', 'investigatorFullName': 'Asma Abdus Salam', 'investigatorAffiliation': 'Aga Khan University'}}}}