Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

NCT05997004 | Completed DMC

• 1 other identifier: NAMS Nepal
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery?
• If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic surgery induced bradycardia?

Conditions

Bradyarrhythmia; Cardiac Arrest; Tachycardia; Asystole

Keywords

Glycopyrrolate; Bradyarrhythmia; Laparoscopy; Pneumoperitoneum; Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Heart Rate (Bradycardia)

  The primary outcome will be Bradycardia defined as heart rate below 60beats per minute

  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)

Secondary Outcomes (3)

• Systolic Blood Pressure

  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)

• Diastolic Blood Pressure

  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)

• Mean Arterial Pressure

  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)

Study Arms (2)

Control

PLACEBO COMPARATOR

31 participants received 1ml of Normal Saline

Drug: Normal Saline

Glyco

EXPERIMENTAL

31 participants received 1ml (0.2mg) of Glycopyrrolate

Drug: Glycopyrrolate

Interventions

Normal Saline DRUG

After surgical creation of umbilical port Control group received injection normal saline 1ml.

Control

Glycopyrrolate DRUG

After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg

Glyco

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of either sex aged 15-65 years
• Patient undergoing elective laparoscopic cholecystectomy
• American Society of Anesthesiologists (ASA) physical status I

You may not qualify if:

• Patients with history of recent or past cardiac diseases
• Patients with pre-operative heart rate ≤60beats/min.
• Patients on cardiac medications
• Allergic to Glycopyrrolate

Sponsors & Collaborators

• National Academy of Medical Sciences, Nepal: lead

Study Sites (1)

National Academy of Medical Sciences

Kathmandu, Nepal

Location

MeSH Terms

Conditions

Bradycardia; Heart Arrest; Tachycardia; Pneumoperitoneum

Interventions

Saline Solution; Glycopyrrolate

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Brihaspati K C, MD

  NAMS Bir Hospital

  PRINCIPAL INVESTIGATOR

• Brahmadev Jha, MD

  NAMS Bir Hospital

  STUDY CHAIR

• Surendra Bhusal, MD

  NAMS Bir Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 18, 2023
• Study Start: May 1, 2018
• Primary Completion: May 20, 2019
• Study Completion: November 15, 2019
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

NE (1)