Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-01 @ 7:58 PM
Study NCT ID:
NCT05997004
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2023-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D006024', 'term': 'Glycopyrrolate'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomly assigned to two groups having 31 in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate (Bradycardia)', 'timeFrame': 'Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)', 'description': 'The primary outcome will be Bradycardia defined as heart rate below 60beats per minute'}], 'secondaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)', 'description': 'Monitoring of systolic Blood pressure'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)', 'description': 'Monitoring of diastolic Blood pressure'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)', 'description': 'Monitoring of Mean Arteria pressure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glycopyrrolate', 'Bradyarrhythmia', 'Laparoscopy', 'Pneumoperitoneum', 'Cardiac Arrest'], 'conditions': ['Bradyarrhythmia', 'Cardiac Arrest', 'Tachycardia', 'Asystole']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the incidence of bradycardia during laparoscopic cholecystectomy. The main question\\[s\\] it aims to answer are:\n\n* Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery?\n* If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic surgery induced bradycardia?', 'detailedDescription': "The emergence of laparoscopic surgery has changed the way of approach for several organs. Despite several advantages, laparoscopic surgery may result in serious complications due to the physiologic changes which occur during the procedure. The cardiovascular system is one of the most challenged systems of the human body during laparoscopy. The insufflation of gas into the peritoneal cavity can provoke arrhythmias. Their incidence is as high as 14-27% of laparoscopies which is higher than in 'open' surgery. The life-threatening bradyarrhythmia (sinus bradycardia, nodal rhythm, atrio-ventricular dissociation and asystole) are frequently encountered during laparoscopic procedure which are due to a vagal-mediated cardiovascular reflex initiated by rapid stretching of the peritoneum at the beginning of peritoneal insufflation. There are studies addressing measures to prevent or control cardiovascular catastrophes during laparoscopic cholecystectomy. Some studies suggest administration of anticholinergic agents especially glycopyrrolate and atropine for prevention of bradycardia during intra-abdominal laparoscopic surgeries. Whereas some study suggests judicious use of Atropine as it increases the risk of tachyarrhythmia. Glycopyrrolate is a synthetic anticholinergic commonly used as a preoperative antimuscarinic agent to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and free acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation.\n\nHYPOTHESIS Glycopyrrolate administration reduces the incidence of bradycardia during Laparoscopic Cholecystectomy.\n\nGeneral objectives To evaluate the role of Glycopyrrolate on prevention of bradyarrhythmia during Laparoscopic cholecystectomy.\n\nSpecific objective\n\n1. To evaluate the change in heart rate and rhythm at different time interval after pneumoperitoneum.\n2. To evaluate the change in Systolic, diastolic and Mean arterial blood pressure at different time interval after pneumoperitoneum."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients of either sex aged 15-65 years\n2. Patient undergoing elective laparoscopic cholecystectomy\n3. American Society of Anesthesiologists (ASA) physical status I\n\nExclusion Criteria:\n\n1. Patients with history of recent or past cardiac diseases\n2. Patients with pre-operative heart rate ≤60beats/min.\n3. Patients on cardiac medications\n4. Allergic to Glycopyrrolate'}, 'identificationModule': {'nctId': 'NCT05997004', 'briefTitle': 'Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Academy of Medical Sciences, Nepal'}, 'officialTitle': 'Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'NAMS Nepal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '31 participants received 1ml of Normal Saline', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Glyco', 'description': '31 participants received 1ml (0.2mg) of Glycopyrrolate', 'interventionNames': ['Drug: Glycopyrrolate']}], 'interventions': [{'name': 'Normal Saline', 'type': 'DRUG', 'description': 'After surgical creation of umbilical port Control group received injection normal saline 1ml.', 'armGroupLabels': ['Control']}, {'name': 'Glycopyrrolate', 'type': 'DRUG', 'description': 'After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg', 'armGroupLabels': ['Glyco']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kathmandu', 'country': 'Nepal', 'facility': 'National Academy of Medical Sciences', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}], 'overallOfficials': [{'name': 'Brihaspati K C, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NAMS Bir Hospital'}, {'name': 'Brahmadev Jha, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NAMS Bir Hospital'}, {'name': 'Surendra Bhusal, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NAMS Bir Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Academy of Medical Sciences, Nepal', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brihaspati K C', 'investigatorAffiliation': 'National Academy of Medical Sciences, Nepal'}}}}