Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT03850093
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2019-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017298', 'term': 'Bisoprolol'}, {'id': 'D014815', 'term': 'Vitamins'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nakera35@hotmail.com', 'phone': '00201005720754', 'title': 'assistant professor Abeer M. Elnakera', 'organization': 'faculty of medicine- Zagazig university'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'small sample size, short study period (until 6 hrs. postoperatively) and unavailability of BIS index monitoring.'}}, 'adverseEventsModule': {'timeFrame': 'intra-operative and up to 6 hours postoperative', 'description': 'hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting', 'eventGroups': [{'id': 'EG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 10, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'hypertension', 'notes': 'MAP elevation by more than 20% from baseline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 20, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tachycardia', 'notes': 'HR more than 90 beats/min', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 18, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'postoperative nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'postoperative vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'agitation on recovery', 'notes': 'Richmond Agitation Sedation Scale (RASS) equal +2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'hypotension', 'notes': 'SAP less than 90 mmHg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bradycardia', 'notes': 'HR less than 60 beats/min', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Surgical Field Visibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'title': '15 minutes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': '30 minutes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': '45 minutes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '60 minutes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': '75 minutes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '90 minutes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': '105 minutes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end', 'description': 'according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding.\n\n1. Slight bleeding- no blood suctioning required.\n2. Slight bleeding- occasional blood suctioning required.\n3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation.\n4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation.\n5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '40'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '30'}, {'value': '80', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '110'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'at the end of surgery', 'description': 'total intraoperative blood loss (mL)', 'unitOfMeasure': 'mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'title': 'preinduction', 'categories': [{'measurements': [{'value': '82.6', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '73.1', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '85.8', 'spread': '16', 'groupId': 'OG002'}]}]}, {'title': 'after induction', 'categories': [{'measurements': [{'value': '74.9', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '67.8', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '85.9', 'spread': '16.7', 'groupId': 'OG002'}]}]}, {'title': '1 minute after intubation', 'categories': [{'measurements': [{'value': '83.3', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '96.2', 'spread': '18.8', 'groupId': 'OG002'}]}]}, {'title': '5 minutes after intubation', 'categories': [{'measurements': [{'value': '77.1', 'spread': '10', 'groupId': 'OG000'}, {'value': '70.6', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '89.3', 'spread': '17.5', 'groupId': 'OG002'}]}]}, {'title': '10 minutes after intubation', 'categories': [{'measurements': [{'value': '75.4', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '66.3', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '87.8', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': '15 minutes after intubation', 'categories': [{'measurements': [{'value': '74.7', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '66.6', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '90.2', 'spread': '19.8', 'groupId': 'OG002'}]}]}, {'title': '30 minutes after intubation', 'categories': [{'measurements': [{'value': '73.4', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '85.8', 'spread': '14.3', 'groupId': 'OG002'}]}]}, {'title': '45 minutes after intubation', 'categories': [{'measurements': [{'value': '75', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '80.1', 'spread': '14.7', 'groupId': 'OG002'}]}]}, {'title': '60 minutes after intubation', 'categories': [{'measurements': [{'value': '75.3', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '66.3', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '87.3', 'spread': '13.5', 'groupId': 'OG002'}]}]}, {'title': '75 minutes after intubation', 'categories': [{'measurements': [{'value': '75.7', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '66', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '84.5', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': '90 minutes after intubation', 'categories': [{'measurements': [{'value': '72.7', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '66.5', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '88.1', 'spread': '14.3', 'groupId': 'OG002'}]}]}, {'title': '105 minutes after intubation', 'categories': [{'measurements': [{'value': '75.7', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '67.4', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '97', 'spread': '13.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery', 'description': 'effect of intervention on the change of heart rate allover study period', 'unitOfMeasure': 'beats/ minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Arterial Blood Pressure Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'title': 'preinduction', 'categories': [{'measurements': [{'value': '85.6', 'spread': '6', 'groupId': 'OG000'}, {'value': '86.4', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '92.4', 'spread': '9.8', 'groupId': 'OG002'}]}]}, {'title': 'after induction', 'categories': [{'measurements': [{'value': '74.4', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '78.2', 'spread': '9.1', 'groupId': 'OG002'}]}]}, {'title': '1 minute after intubation', 'categories': [{'measurements': [{'value': '80.6', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '92.2', 'spread': '16.1', 'groupId': 'OG002'}]}]}, {'title': '5 minutes after intubation', 'categories': [{'measurements': [{'value': '70.7', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '78.6', 'spread': '11.1', 'groupId': 'OG002'}]}]}, {'title': '10 minutes after intubation', 'categories': [{'measurements': [{'value': '66.4', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '76.5', 'spread': '12.9', 'groupId': 'OG002'}]}]}, {'title': '15 minutes after intubation', 'categories': [{'measurements': [{'value': '65.4', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '70.2', 'spread': '8.8', 'groupId': 'OG001'}, {'value': '74', 'spread': '12.1', 'groupId': 'OG002'}]}]}, {'title': '30 minutes after intubation', 'categories': [{'measurements': [{'value': '64.4', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '66.2', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '66.6', 'spread': '21.7', 'groupId': 'OG002'}]}]}, {'title': '45 minutes after intubation', 'categories': [{'measurements': [{'value': '63.3', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '64.7', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '64.6', 'spread': '14.3', 'groupId': 'OG002'}]}]}, {'title': '60 minutes after intubation', 'categories': [{'measurements': [{'value': '61.9', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '66.7', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '69.9', 'spread': '11.3', 'groupId': 'OG002'}]}]}, {'title': '75 minutes after intubation', 'categories': [{'measurements': [{'value': '62.5', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '69.4', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '67.7', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': '90 minutes after intubation', 'categories': [{'measurements': [{'value': '63', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '62.7', 'spread': '12.8', 'groupId': 'OG002'}]}]}, {'title': '105 minutes after intubation', 'categories': [{'measurements': [{'value': '63.1', 'spread': '3', 'groupId': 'OG000'}, {'value': '67.2', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '70', 'spread': '14.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery', 'description': 'effect of intervention on the change of mean arterial blood pressure allover study period', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Surgeon Satisfaction (Categorical)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'title': 'surgeon satisfaction achieved (score≥ 4)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'surgeon satisfaction not achieved(score< 4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the end of surgery', 'description': 'surgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the end of surgery', 'description': 'need for additional intraoperative IV vasodilators (nitroglycerine', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the end of surgery', 'description': 'the need for additional beta blockers (propranolol)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at the end of surgery', 'description': 'need for both IV nitroglycerine and propranolol intraoperatively', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Visual Analogue Scale (VAS) for Postoperative Pain', 'timeFrame': '1, 3 and 6 hrs. after recovery', 'description': 'postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Visual Analogue Scale (VAS) for Postoperative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'title': 'on full recovery', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '6'}]}]}, {'title': '3hrs. after recovery', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '3', 'upperLimit': '4'}]}]}, {'title': '6hrs after recovery', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0n full recovery, 3 and 6 hrs. after recovery', 'description': 'postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to 1st Postoperative Rescue Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'OG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'OG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '90'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '50'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'on administration of 1st postoperative rescue analgesia', 'description': 'time to 1st postoperative rescue analgesia (starting from administration of the studied drug)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gabapentin Group (Group G)', 'description': '21 patients completed the study and were considered for statistical analysis'}, {'id': 'FG001', 'title': 'Bisoprolol Group (Group B)', 'description': '22 patients were allocated to group B, completed the study and were considered for statistical analysis'}, {'id': 'FG002', 'title': 'Control Group (Group C)', 'description': '17 patients completed the study and were considered for statistical analysis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '66 patients who underwent endoscopic sinus surgery were eligible for the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative'}, {'id': 'BG001', 'title': 'Bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative'}, {'id': 'BG002', 'title': 'Control', 'description': 'placebo was given to patients of control group 2 hours preoperative'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '5.1', 'groupId': 'BG002'}, {'value': '27.93', 'spread': '6.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'weight, continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '87.1', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '87.9', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '84.5', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '85.62', 'spread': '11.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "patients' withdrawal from the study"}, {'title': 'indication for surgery, categorical)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'title': 'polyp', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'sinusitis', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'indication for surgery is either due to polyp or sinusitis', 'unitOfMeasure': 'Participants', 'populationDescription': '3 patients were withdrawn from the study'}, {'title': 'mean arterial blood pressure (MAP), continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '96.6', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '92.9', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '88.2', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '93.4', 'spread': '9.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '3 patients were withdrawn from the study'}, {'title': 'heart rate (HR), continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '91.1', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '82.9', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '83.8', 'spread': '14.8', 'groupId': 'BG002'}, {'value': '86.7', 'spread': '11.98', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '3 patients were withdrawn from the study'}, {'title': 'side of surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'categories': [{'title': 'bilateral', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'unilateral', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'side of surgery is either bilateral or unilateral', 'unitOfMeasure': 'Participants', 'populationDescription': '3 patients were withdrawn from the study'}], 'populationDescription': "63 patients were enrolled in the study. after 3 patients' withdrawal, 60 patients completed the study and considered for statistical analysis"}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-15', 'size': 142252, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-22T12:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-01', 'studyFirstSubmitDate': '2019-02-18', 'resultsFirstSubmitDate': '2019-02-22', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-01', 'studyFirstPostDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Surgeon Satisfaction (Categorical)', 'timeFrame': 'at the end of surgery', 'description': 'surgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups'}, {'measure': 'Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure', 'timeFrame': 'at the end of surgery', 'description': 'need for additional intraoperative IV vasodilators (nitroglycerine'}, {'measure': 'Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure', 'timeFrame': 'at the end of surgery', 'description': 'the need for additional beta blockers (propranolol)'}, {'measure': 'Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure', 'timeFrame': 'at the end of surgery', 'description': 'need for both IV nitroglycerine and propranolol intraoperatively'}, {'measure': 'Visual Analogue Scale (VAS) for Postoperative Pain', 'timeFrame': '1, 3 and 6 hrs. after recovery', 'description': 'postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed'}, {'measure': 'Visual Analogue Scale (VAS) for Postoperative Pain', 'timeFrame': '0n full recovery, 3 and 6 hrs. after recovery', 'description': 'postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain'}, {'measure': 'Time to 1st Postoperative Rescue Analgesia', 'timeFrame': 'on administration of 1st postoperative rescue analgesia', 'description': 'time to 1st postoperative rescue analgesia (starting from administration of the studied drug)'}], 'primaryOutcomes': [{'measure': 'Changes in Surgical Field Visibility', 'timeFrame': 'scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end', 'description': 'according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding.\n\n1. Slight bleeding- no blood suctioning required.\n2. Slight bleeding- occasional blood suctioning required.\n3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation.\n4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation.\n5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.'}, {'measure': 'Blood Loss', 'timeFrame': 'at the end of surgery', 'description': 'total intraoperative blood loss (mL)'}], 'secondaryOutcomes': [{'measure': 'Heart Rate Change', 'timeFrame': 'were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery', 'description': 'effect of intervention on the change of heart rate allover study period'}, {'measure': 'Mean Arterial Blood Pressure Change', 'timeFrame': 'were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery', 'description': 'effect of intervention on the change of mean arterial blood pressure allover study period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gabapentin', 'bisoprolol', 'hemodynamic', 'surgical field'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': "the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate .\n\nA prospective randomized double blinded controlled study. Eligible patients were randomized according to random list generated software and allocated into 3 equal and matched groups (15 patients in each group):-\n\n* Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200 mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of anesthesia.\n* Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5 mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of anesthesia.\n* Group C: control group in which Patients were premedicated with oral placebo with sips of water, 2 hours before induction of anesthesia.", 'detailedDescription': "Hypothesis:\n\nGabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate.\n\nObjectives Compare the effect of preoperative Gabapentin with Bisoprolol on hemodynamics, surgical field optimization during endoscopic nasal surgeries.\n\nTechnical design:\n\nA) Site of study :\n\nThe study was conducted at Anesthesia and Surgical intensive care and Otorhinolaryngology departments, faculty of medicine, Zagazig University.\n\nB) Sample Size :\n\nAccording to 80% power of the study, 95% CI and calculated volume of blood loss 200±40 ml and 150±55ml on Gabapentin (22) and Bisoprolol (15) premedication respectively, the estimated Sample size was 54 patients (open EPI) , 63 patients were included in the study to compensate for drop out.\n\nRandomization was carried out on 63 patients to compensate for drop out . All planned ESS procedures was managed by the same anesthetist and surgeon who were blinded to the used study's premedication. The surgeon was blinded to the monitor recording the hemodynamic variables.\n\nAll patients had been preoperatively evaluated according to standard local protocol. Preoperative surgical preparation and proper management of infection were confirmed to every patient.\n\nPatient was premedicated by IV ranitidine 50 mg, midazolam 0.05 mg/kg and atropine 20µg/kg immediately before admission to the operating room.\n\nOn admission to the operating room, Standard monitoring included 5 leads ECG, non-invasive blood pressure, Pulse Oximetry and End-tidal carbon dioxide (ETCO2) trace were applied (B40i Monitor - GE Healthcare, Finland).\n\nAnesthesia was induced with IV propofol 2 mg/kg and fentanyl 1 µg/kg was given for analgesia. Cisatracurium 0.15 mg/kg IV was given to facilitate direct laryngoscopy and orotracheal intubation. The patient was ventilated at tidal volume 6-8mL/kg and respiratory rate that achieved ETCO2 of 30-35 mmHg. Oropharyngeal pack was inserted.\n\nAnesthesia was maintained by isoflurane based on MAC 1.2 % until a steady state of anesthesia was achieved (defined as a state of anesthesia when no changes in hemodynamic variables take place for at least 10 min). An increase of ≥ 20% of basal value in both HR and MAP was treated with increasing the concentration of isoflurane by 0.5% and increments of fentanyl 1 μg/kg. Muscle relaxation was confirmed by cisatracurium 0.03mg/kg every 20 mins. IV lactated ringer solution was infused at approximately 6ml/kg/hr till the end of the procedure.\n\nAll patients were positioned supine and the bed-head of the surgical table was raised by 30° to improve venous drainage.\n\nBefore the beginning of surgical procedure, well wrung out cotton pledgets soaked with 4 ml of 2% lignocaine with 1:200,000 adrenaline were topically applied to the nasal mucous membrane for 10 min (no infiltration).\n\nTechnique for hemodynamic optimization:\n\nTarget mean arterial pressure (MAP) was 60-70 mmHg during the surgical procedure to achieve Fromm and Boezaart category scale of 2 or 3 which is judged to be optimal for surgery (20).\n\nIf the MAP was still ˃70mmHg in spite of increasing isoflurane inhalation to 2.5%, nitroglycerine (1-10 μg/kg/min.) titrated to effect.\n\nIf the heart rate was more than 100 beats/ minute, propranolol was titrated 1-3 mg/hour to achieve target MAP.\n\nIf mean arterial pressure (MAP) decreased to less than 60 mm Hg, ephedrine in increments of 3 mg was given.\n\nWithdrawal vasoactive agents:\n\nAfter recording the surgeons' opinion regarding the surgical field and about 15 minutes before ending surgery, the infusion of any vasoactive medication (if used) was stopped and the anesthetic agent was decreased allowing HR and MAP to return to their basal value. If Hypotension (defined as SAP\\< 90mmHg and bradycardia less than 60 bpm) persisted, they was treated by ephedrine in increments of 3 mg .\n\nOn compilation of surgical procedure, anesthesia was discontinued and reversal of neuromuscular blockade was achieved using IV neostigmine 0.08 mg/kg and atropine 20µg/kg. After removal of oropharyngeal pack, oropharyngeal suction was performed. On the start of obeying commands, patients were extubated and shifted to recovery room.\n\nPatients were discharged to the ward after reaching a score ≥ 9 on the Modified Aldrete Scoring System.\n\nDuring postoperative period up to 6 hours, the patient was monitored for conscious level, oxygen saturation, heart rate and mean arterial blood pressure.\n\nOn ward admission, IM diclofenac sodium 75mg was given then every 12 hours. If the patient complained moderate to severe pain (VAS≥ 4) meperidine 25mg increments up to pain relief (maximum 100mg as a single dose) was given."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients who underwent functional endoscopic sinus surgery\n* ability to swallow tablets\n\nExclusion Criteria:\n\n* suspected difficult airway\n* basal HR \\<60/min.\n* chronic cardiovascular or cerebrovascular disease\n* bronchial asthma or COPD\n* DM\n* bleeding disorders\n* anemia (Hb level\\< 10 gm/dl)\n* renal or hepatic insufficiency\n* psychiatric disorders\n* chronic treatment by BBs, gabapentin or drugs that affect coagulation\n* acute nasal infection\n* allergy/contraindications to any of the study's drugs."}, 'identificationModule': {'nctId': 'NCT03850093', 'briefTitle': 'Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Preoperative Gabapentin Versus Bisoprolol for Intraoperative Hemodynamic and Surgical Field Optimization During Endoscopic Sinus Surgery', 'orgStudyIdInfo': {'id': 'ZU-IRB 2139-24-5-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gabapentin', 'description': 'gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative', 'interventionNames': ['Drug: Gabapentin1200 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bisoprolol', 'description': 'bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative', 'interventionNames': ['Drug: bisoprolol 2.5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'placebo was given to patients of control group 2 hours preoperative', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Gabapentin1200 mg', 'type': 'DRUG', 'otherNames': ['gaptin'], 'description': 'patients received 1200mg gabapentin 2 hrs preoperative', 'armGroupLabels': ['gabapentin']}, {'name': 'bisoprolol 2.5mg', 'type': 'DRUG', 'otherNames': ['concor'], 'description': 'patients received 2.5mg bisoprolol 2 hrs preoperative', 'armGroupLabels': ['bisoprolol']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['vitamins'], 'description': 'patients received oral placebo 2 hrs preoperative', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Abeer M. Elnakera, doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine - Zagazig university'}, {'name': 'Ayman A. Hassan, doctorate', 'role': 'STUDY_CHAIR', 'affiliation': 'Zagazig University'}, {'name': 'Maram wagdy, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Zagazig University'}, {'name': 'Mohamed W. El-Anwar, doctorate', 'role': 'STUDY_CHAIR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'collective data sheet was available to all researchers during and after completing the study. individual patient records are available on request for all researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor of anesthesia and surgical intensive care', 'investigatorFullName': 'abeer M. elnakera', 'investigatorAffiliation': 'Zagazig University'}}}}