Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Bradyarrhythmia; Cardiac Arrest; Tachycardia; Asystole
• Interventions: Drug: Normal Saline; Drug: Glycopyrrolate

• Registration Number: NCT05997004
• Lead Sponsor: National Academy of Medical Sciences, Nepal

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.

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-05-20
• Study Completion: 2019-11-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-18
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal Saline	31 participants received 1ml of Normal Saline
Glyco	Glycopyrrolate	31 participants received 1ml (0.2mg) of Glycopyrrolate

Primary Outcome Measures

Name	Time	Method
Heart Rate (Bradycardia)	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)	The primary outcome will be Bradycardia defined as heart rate below 60beats per minute

Secondary Outcome Measures

Name	Time	Method
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)	Monitoring of systolic Blood pressure
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)	Monitoring of diastolic Blood pressure
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)	Monitoring of Mean Arteria pressure

Trial Locations

Locations (1)

National Academy of Medical Sciences; 🇳🇵 Kathmandu, Nepal