Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT03793751
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2018-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'debsanjay@gmail.com', 'phone': '+91-9431166582', 'title': 'Dr.Deb Sanjay Nag', 'organization': 'Tata Main Hospital, Tata Steel'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the hospital admission upto 7 days after day of surgery', 'description': 'Common adverse effects of dexmedetomidine: Hypotension, hypertension, bradycardia, dry mouth and nausea. Other reported adverse effects include fever, rigors, cyanosis, muscle weakness. It may lead to arrhythmias, AV Block, cardiac arrest, T-wave inversion, tachycardia, angina pectoris, pulmonary edema, bronchospasm, respiratory depression, syncope, neuropathy, paresthesia, paresis, hyperkalaemia, lactic acidosis and hyperglycaemia.', 'eventGroups': [{'id': 'EG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Cases Developing POCD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.'}, {'id': 'OG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-7 days', 'description': 'Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The "Montreal Cognitive Assessment" (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.'}, {'id': 'OG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.'}], 'classes': [{'title': 'T0', 'categories': [{'measurements': [{'value': '129.07', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '125.4', 'spread': '10.44', 'groupId': 'OG001'}]}]}, {'title': 'T1', 'categories': [{'measurements': [{'value': '130.78', 'spread': '19.46', 'groupId': 'OG000'}, {'value': '125.45', 'spread': '10.81', 'groupId': 'OG001'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '128.22', 'spread': '13.78', 'groupId': 'OG000'}, {'value': '127.48', 'spread': '8.39', 'groupId': 'OG001'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '126.22', 'spread': '13.91', 'groupId': 'OG000'}, {'value': '123.03', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '122.93', 'spread': '13.47', 'groupId': 'OG000'}, {'value': '119.1', 'spread': '13.06', 'groupId': 'OG001'}]}]}, {'title': 'T5', 'categories': [{'measurements': [{'value': '117.71', 'spread': '10.73', 'groupId': 'OG000'}, {'value': '115.97', 'spread': '11.43', 'groupId': 'OG001'}]}]}, {'title': 'T6', 'categories': [{'measurements': [{'value': '115.88', 'spread': '10.65', 'groupId': 'OG000'}, {'value': '113.5', 'spread': '10.89', 'groupId': 'OG001'}]}]}, {'title': 'T7', 'categories': [{'measurements': [{'value': '117.71', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '131.33', 'spread': '15.31', 'groupId': 'OG001'}]}]}, {'title': 'T8', 'categories': [{'measurements': [{'value': '136.00', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '155.00', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured every 10 minutes upto 80 minutes, T0 as the initial reading.', 'description': 'Intraoperative Systolic Blood Pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intraoperative Systolic Blood Pressure'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.'}, {'id': 'OG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.'}], 'classes': [{'title': 'T0', 'categories': [{'measurements': [{'value': '79.48', 'spread': '9.38', 'groupId': 'OG000'}, {'value': '80.40', 'spread': '8.59', 'groupId': 'OG001'}]}]}, {'title': 'T1', 'categories': [{'measurements': [{'value': '78.92', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '78.15', 'spread': '11.19', 'groupId': 'OG001'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '78.53', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '80.17', 'spread': '8.96', 'groupId': 'OG001'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '75.15', 'spread': '9.34', 'groupId': 'OG000'}, {'value': '77.02', 'spread': '10.28', 'groupId': 'OG001'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '74.32', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '72.77', 'spread': '10.48', 'groupId': 'OG001'}]}]}, {'title': 'T5', 'categories': [{'measurements': [{'value': '72.69', 'spread': '7.78', 'groupId': 'OG000'}, {'value': '70.43', 'spread': '11.96', 'groupId': 'OG001'}]}]}, {'title': 'T6', 'categories': [{'measurements': [{'value': '71.62', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '68.38', 'spread': '10.06', 'groupId': 'OG001'}]}]}, {'title': 'T7', 'categories': [{'measurements': [{'value': '71.79', 'spread': '6.97', 'groupId': 'OG000'}, {'value': '78', 'spread': '7.81', 'groupId': 'OG001'}]}]}, {'title': 'T8', 'categories': [{'measurements': [{'value': '75.67', 'spread': '5.51', 'groupId': 'OG000'}, {'value': '90.00', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured every 10 minutes upto 80 minutes, T0 as the initial reading.', 'description': 'Intraoperative Diastolic Blood Pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Diastolic Blood Pressure'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.'}, {'id': 'OG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.'}], 'classes': [{'title': 'T0', 'categories': [{'measurements': [{'value': '75.00', 'spread': '11.21', 'groupId': 'OG000'}, {'value': '81.90', 'spread': '7.09', 'groupId': 'OG001'}]}]}, {'title': 'T1', 'categories': [{'measurements': [{'value': '74.80', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '82.02', 'spread': '6.84', 'groupId': 'OG001'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '79.8', 'spread': '11.37', 'groupId': 'OG000'}, {'value': '82.02', 'spread': '6.81', 'groupId': 'OG001'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '77.97', 'spread': '11.27', 'groupId': 'OG000'}, {'value': '82.65', 'spread': '6.57', 'groupId': 'OG001'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '76.32', 'spread': '11.08', 'groupId': 'OG000'}, {'value': '83.20', 'spread': '6.18', 'groupId': 'OG001'}]}]}, {'title': 'T5', 'categories': [{'measurements': [{'value': '76.15', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '84.00', 'spread': '6.10', 'groupId': 'OG001'}]}]}, {'title': 'T6', 'categories': [{'measurements': [{'value': '74.76', 'spread': '10.59', 'groupId': 'OG000'}, {'value': '85.35', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'T7', 'categories': [{'measurements': [{'value': '70.17', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '86.67', 'spread': '9.24', 'groupId': 'OG001'}]}]}, {'title': 'T8', 'categories': [{'measurements': [{'value': '69.33', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '95.00', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured every 10 minutes upto 80 minutes, T0 as the initial reading.', 'description': 'Intraoperative Heart Rate', 'unitOfMeasure': 'Beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intraoperative heart rate'}, {'type': 'SECONDARY', 'title': 'Any Adverse Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.'}, {'id': 'OG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-7 days', 'description': 'Observation for any adverse effects', 'unitOfMeasure': 'number of cases', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Insidence of adverse outcomes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.'}, {'id': 'FG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DEX Group', 'description': 'Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.'}, {'id': 'BG001', 'title': 'CONTROL Group', 'description': 'The Control Group will receive placebo infusion of normal saline.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.28', 'spread': '3.93', 'groupId': 'BG000'}, {'value': '68.48', 'spread': '4.96', 'groupId': 'BG001'}, {'value': '68.38', 'spread': '4.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Indian', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Geriatric patients of American Society of Anaesthesiology (ASA) status of I-III between 60-75 years scheduled for elective hip surgery under spinal anaesthesia.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-01', 'size': 216633, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-10T11:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This will be a prospective, randomized, placebo-controlled, double-blind clinical trial. The patients will be recruited according to the inclusion criteria and will be distributed to one of the groups according to computer-generated random assignment. The personnel involved in the study, including statisticians, investigators, anaesthetists, surgeons and the patients will be blinded to the specific experimental scheme implementation Patients will be randomized into one of the two groups using a computer based random number generator. https://www.randomizer.org. All recordings would be performed by an anaesthesiologist blinded to the group allocation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2018-12-30', 'resultsFirstSubmitDate': '2019-12-31', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-10', 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Cases Developing POCD', 'timeFrame': '0-7 days', 'description': 'Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The "Montreal Cognitive Assessment" (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Measured every 10 minutes upto 80 minutes, T0 as the initial reading.', 'description': 'Intraoperative Systolic Blood Pressure'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Measured every 10 minutes upto 80 minutes, T0 as the initial reading.', 'description': 'Intraoperative Diastolic Blood Pressure'}, {'measure': 'Heart Rate', 'timeFrame': 'Measured every 10 minutes upto 80 minutes, T0 as the initial reading.', 'description': 'Intraoperative Heart Rate'}, {'measure': 'Any Adverse Outcome', 'timeFrame': '0-7 days', 'description': 'Observation for any adverse effects'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years undergoing hip surgery under spinal anaesthesia.', 'detailedDescription': 'Postoperative cognitive dysfunction (POCD) is a common postoperative neurological complication in elderly. POCD is a subtle impairment of memory, concentration and information processing with clinical manifestations of delirium, anxiety, personality changes and impaired memory, which is associated with prolonged hospitalization, a reduced quality of life and an increase in morbidity and mortality. Dexmedetomidine is a highly selective α-2 adrenergic receptor agonist with a dose-dependent sedative hypnotic effect. It has also been reported that dexmedetomidine has a potential role in preventing POCD due to its neuroprotective effects both in vitro and in vivo.\n\nTill date very few studies have analysed the impact of dexmedetomidine on early POCD. Even in the few available studies compared assessment of POCD using the Mini-Mental State Examination (MMSE) scores and found that MMSE have lower sensitivity for identifying Cognitive Dysfunction as compared to Montreal Cognitive Assessment (MoCA). The study would analyze the impact of Intraoperative Dexmedetomidine infusion on early Postoperative Cognitive Dysfunction (POCD) in geriatric patients above 60 years undergoing hip surgery under spinal anesthesia.\n\nSo this study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years undergoing hip surgery under spinal anaesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American society of Anesthesiology (ASA) status of I-III\n* Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia\n\nExclusion Criteria:\n\n* Patient not willing to be a part of the study\n* Patients were aged \\<60 or \\>75 years\n* Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance\n* Patients suffering from preoperative bradycardia \\[heart rate (HR) \\<60 bpm\\] or hypotension \\[mean arterial blood pressure (MAP) \\<70 mmHg\\]\n* Patients who had recently received a sedative or opioid drug\n* Patients with a MoCA (Montreal Cognitive Assessment) score \\<26\n* Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT03793751', 'briefTitle': 'Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Tata Main Hospital'}, 'officialTitle': 'Effect of Intraoperative Dexmedetomidine Infusion on Early Postoperative Cognitive Dysfunction (POCD) in Geriatric Patients Undergoing Hip Surgery Under Spinal Anaesthesia', 'orgStudyIdInfo': {'id': '201-26104-172-215441'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEX Group', 'description': 'Receiving Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.', 'interventionNames': ['Drug: Dexmedetomidine Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CONTROL Group', 'description': 'The Control Group will receive an equal volume placebo infusion of normal saline.', 'interventionNames': ['Drug: Dexmedetomidine Injection']}], 'interventions': [{'name': 'Dexmedetomidine Injection', 'type': 'DRUG', 'otherNames': ['Normal Saline as placebo'], 'description': 'Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.', 'armGroupLabels': ['CONTROL Group', 'DEX Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '831011', 'city': 'Jamshedpur', 'state': 'Jharkhand', 'country': 'India', 'facility': 'Dr.Deb Sanjay Nag', 'geoPoint': {'lat': 22.80278, 'lon': 86.18545}}], 'overallOfficials': [{'name': 'Dr.Deb S Nag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tata Main Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Main Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Dr.Deb Sanjay Nag', 'investigatorAffiliation': 'Tata Main Hospital'}}}}