Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

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?

Study Overview

• Status: Completed
• Conditions: Tachycardia; Cardiac Arrest; Asystole; Bradyarrhythmia
• Intervention / Treatment: Drug: Normal Saline; Drug: Glycopyrrolate

Detailed Description

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.

HYPOTHESIS Glycopyrrolate administration reduces the incidence of bradycardia during Laparoscopic Cholecystectomy.

General objectives To evaluate the role of Glycopyrrolate on prevention of bradyarrhythmia during Laparoscopic cholecystectomy.

Specific objective

1. To evaluate the change in heart rate and rhythm at different time interval after pneumoperitoneum.
2. To evaluate the change in Systolic, diastolic and Mean arterial blood pressure at different time interval after pneumoperitoneum.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Kathmandu, Nepal
    • National Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; 31 participants received 1ml of Normal Saline	Drug: Normal Saline; After surgical creation of umbilical port Control group received injection normal saline 1ml.
Experimental: Glyco; 31 participants received 1ml (0.2mg) of Glycopyrrolate	Drug: Glycopyrrolate; After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Monitoring of 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	Monitoring of 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	Monitoring of Mean Arteria 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)

Collaborators and Investigators

• Sponsor: National Academy of Medical Sciences, Nepal
• Investigators: Principal Investigator: Brihaspati K C, MD, NAMS Bir Hospital; Study Chair: Brahmadev Jha, MD, NAMS Bir Hospital; Study Chair: Surendra Bhusal, MD, NAMS Bir Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Cardiac Arrest; Laparoscopy; Glycopyrrolate; Bradyarrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Bradycardia; Heart Arrest; Tachycardia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: NAMS Nepal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No