Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-29 @ 11:33 AM
Study NCT ID:
NCT06560892
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2024-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of analgesia', 'timeFrame': '24 hours', 'description': 'The duration of postoperative analgesia was calculated as the time in minutes starting after the dressing of the patient in the operation room until the patient had a VAS≥3.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['LAPAROSCOPIC CHOLECYSTECTOMY']}, 'descriptionModule': {'briefSummary': 'For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either gender\n* Aged between 20 and 70 years\n* ASA (American Society of Anesthesiologists Classification) physical status I and II\n* Undergoing Laparoscopic Cholecystectomy under general anesthesia\n\nExclusion Criteria:\n\n* Patients sensitive to local anesthetics\n* Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).\n* Patients with uncontrolled diabetes (FBS≥110 mg/dl)\n* Uncontrolled blood pressure (SBP≥140 mmHg)\n* Ischemic heart disease (EF≤40%)\n* Pulmonary dysfunction (FEV≤70 percent of normal)'}, 'identificationModule': {'nctId': 'NCT06560892', 'briefTitle': 'Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Comparison Between Mean Duration of Post-operative Analgesia of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine Following Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'DRQAZIANEESBVH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine group', 'description': 'Patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline', 'interventionNames': ['Drug: Bupivacaine injection']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine + Dexmedetomidine group', 'description': 'Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml', 'interventionNames': ['Drug: Bupivacaine injection', 'Drug: Dexmedetomidine injection']}], 'interventions': [{'name': 'Bupivacaine injection', 'type': 'DRUG', 'otherNames': ['Local anesthetic'], 'description': 'patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline.', 'armGroupLabels': ['Bupivacaine + Dexmedetomidine group', 'Bupivacaine group']}, {'name': 'Dexmedetomidine injection', 'type': 'DRUG', 'otherNames': ['Local anesthetic'], 'description': 'Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml.', 'armGroupLabels': ['Bupivacaine + Dexmedetomidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06318', 'city': 'Bahawalpur', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Quaid-e-Azam Medical College', 'geoPoint': {'lat': 29.39779, 'lon': 71.6752}}], 'overallOfficials': [{'name': 'Qazi Anees, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bahawal Victoria Hospital'}, {'name': 'Syed Shakeel Ahmed, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahida Islam Teaching Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared with other researchers on a reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RESnTEC, Institute of Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bahawal Victoria Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}