Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06065956
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2023-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Hemodynamic Changes With Morphine Versus Esmolol During Induction of Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-01', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-10-01', 'lastUpdatePostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '06 months', 'description': 'Change in blood pressure between baseline value and post Intubation value will be measured in millimeter of mercury (mmHg).'}, {'measure': 'Pulse rate', 'timeFrame': '06 months', 'description': 'Change in pulse rate between baseline value and post intubation value will be measured per minute.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation Complication']}, 'descriptionModule': {'briefSummary': 'Comparing hemodynamic changes with morphine versus esmolol as an adjuvant agent during induction of Anaesthesia', 'detailedDescription': 'Comparing hemodynamic profile of patients during induction of General Anesthesia with intravenous morphine as an adjuvant drug versus Intravenous esmolol as an adjuvant agent,My aim is to study which drug has superior hemodynamic profile in terms of hemodynamic stability of patient requiring General Anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 2 patients presenting for elective surgery.\n\nExclusion Criteria:\n\n* Patients having major cardiac disease.\n* Metastatic disease.\n* Pregnant females.\n* Those unwilling to be part of study.'}, 'identificationModule': {'nctId': 'NCT06065956', 'briefTitle': 'Comparison of Hemodynamic Changes With Morphine Versus Esmolol During Induction of Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Pakistan Navy Station Shifa Hospital'}, 'officialTitle': 'Comparison of Hemodynamic Changes With Morphine Versus Esmolol as an Adjuvant Agent During Induction of Anaesthesia', 'orgStudyIdInfo': {'id': '433/8/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morphine group', 'description': 'Half of participants will be comprising of morphine group', 'interventionNames': ['Drug: Intravenous morphine']}, {'type': 'EXPERIMENTAL', 'label': 'Esmolol group', 'description': 'Half of participants will be comprising of esmolol group', 'interventionNames': ['Drug: Intravenous morphine']}], 'interventions': [{'name': 'Intravenous morphine', 'type': 'DRUG', 'otherNames': ['Intravenous esmolol'], 'description': 'Morphine group(an opioid), participants were given intravenous morphine(an opioid) at induction of General Anaesthesia before laryngoscopy and intubation.\n\nThe other group,Esmolol group(cardioselective beta blocker), participants were given intravenous esmolol(cardioselective beta blocker) during induction of General Anesthesia before laryngoscopy and intubation.', 'armGroupLabels': ['Esmolol group', 'Morphine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'PNS Shifa Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Navy Station Shifa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'FCPS 2 Registrar in Anaesthesiology', 'investigatorFullName': 'Kenan Anwar Khan', 'investigatorAffiliation': 'Pakistan Navy Station Shifa Hospital'}}}}