Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

NCT ID: NCT05997004

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-11-15

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?

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.

Conditions

Bradyarrhythmia; Cardiac Arrest; Tachycardia; Asystole

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control

31 participants received 1ml of Normal Saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

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

Glyco

31 participants received 1ml (0.2mg) of Glycopyrrolate

Group Type: EXPERIMENTAL

Glycopyrrolate

Intervention Type: DRUG

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

Interventions

Normal Saline

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

Intervention Type: DRUG

Glycopyrrolate

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Academy of Medical Sciences, Nepal

OTHER_GOV

Sponsor Role: lead

Responsible Party

Brihaspati K C

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brihaspati K C, MD

Role: PRINCIPAL_INVESTIGATOR

NAMS Bir Hospital

Brahmadev Jha, MD

Role: STUDY_CHAIR

NAMS Bir Hospital

Surendra Bhusal, MD

Role: STUDY_CHAIR

NAMS Bir Hospital

Locations

National Academy of Medical Sciences

Kathmandu, , Nepal

Countries

Nepal

Other Identifiers

NAMS Nepal

Identifier Type: -

Identifier Source: org_study_id