Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparascopic Cholecystectomy

Sponsor

National Academy of Medical Sciences, Nepal (Other)

Overall Status

Completed

CT.gov ID

NCT05997004

Collaborator

(none)

Enrollment

Location

Arms

18.5

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to evaluate the incidence of bradycardia during laparoscopic cholescystectomy. 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?

Condition or Disease	Intervention/Treatment	Phase
Bradyarrhythmia Cardiac Arrest Tachycardia Asystole	Drug: Normal Saline Drug: Glycopyrrolate	N/A

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 Laparascopic cholecystectomy.

Specific objective

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

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparascopic Cholecystectomy

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

May 20, 2019

Actual Study Completion Date :

Nov 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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