Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-29 @ 12:37 PM
Study NCT ID:
NCT02213159
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2014-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2014-08-08', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)', 'timeFrame': 'At discharge from the PACU'}], 'secondaryOutcomes': [{'measure': 'Time to first morphine requirement in PACU', 'timeFrame': 'in the PACU'}, {'measure': 'Numeric Rating Scale (NRS) for Pain', 'timeFrame': 'in the PACU and at 24 hours'}, {'measure': 'NRS for nausea', 'timeFrame': 'in the PACU'}, {'measure': 'incidence of pruritus', 'timeFrame': 'in the PACU'}, {'measure': 'incidence of vomiting or retching', 'timeFrame': 'in the PACU'}, {'measure': 'incidence of respiratory complications', 'timeFrame': 'in the PACU'}, {'measure': 'time to discharge readiness in PACU', 'timeFrame': 'in the PACU'}, {'measure': 'total morphine consumption at 24 hours', 'timeFrame': 'at 24 hours'}, {'measure': 'Quality of Recovery (QoR-40) score at 24 hours', 'timeFrame': 'at 24 hours'}, {'measure': 'overall satisfaction at one month', 'timeFrame': 'one month after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'bariatric surgery', 'postoperative pain', 'morphine consumption', 'Quality of recovery'], 'conditions': ['Obesity', 'Sleep Apnea', 'Diabetes', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.', 'detailedDescription': 'effect of Dexmedetomidine bolus on postoperative morphine requirements'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index \\> 40 kg/m2 or BMI \\> 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea\n* American Society of Anesthesiologists class I or II\n* Undergoing laparoscopic sleeve gastrectomy bariatric surgery\n\nExclusion Criteria:\n\n* Allergy to morphine or its derivatives\n* Allergy to α-2 adrenergic agonists\n* weight over 180 kg\n* history of uncontrolled hypertension\n* heart block greater than first degree\n* prolonged QT interval\n* clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal diseases\n* received an opioid analgesic medication within a 24 h period prior to surgery\n* history of alcohol, drug abuse or chronic opioid intake\n* history of psychiatric disorder\n* pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT02213159', 'briefTitle': 'Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery', 'orgStudyIdInfo': {'id': 'ANES.CZ.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'prior to anticipated end of surgery bolus of 1 microgram/kg Dexmedetomidine intravenously over 10 minutes followed by 0.5 micrograms/kilogram/hour intravenous infusion until removal of laparoscopes', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'description': 'prior to anticipated completion of surgery morphine 0.08 mg/kilogram intravenous bolus over 10 minutes followed by a saline infusion until removal of the laparoscopes', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Morphine', 'type': 'DRUG', 'armGroupLabels': ['Morphine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Carine Zeeni, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUBMC'}, {'name': 'Sahar Siddik, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AUBMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}