Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

Cardiac Arrest Clinical Trial

Official title:

Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05997004
• Other study ID #: NAMS Nepal
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: November 15, 2019

Study information

• Verified date: August 2023
• Source: National Academy of Medical Sciences, Nepal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 15, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asystole
• Bradyarrhythmia
• Bradycardia
• Cardiac Arrest
• Heart Arrest
• Tachycardia

Intervention

Drug:
• Normal Saline
After surgical creation of umbilical port Control group received injection normal saline 1ml.
• Glycopyrrolate
After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg

Locations

Country	Name	City	State
Nepal	National Academy of Medical Sciences	Kathmandu

Sponsors (1)

Lead Sponsor	Collaborator
National Academy of Medical Sciences, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)