Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

Study Overview
=================
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 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.

Official Title
-----------------
Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

Conditions
-----------------
Bradyarrhythmia, Cardiac Arrest, Tachycardia, Asystole

Intervention / Treatment
-----------------
* Drug: Normal Saline
* Drug: Glycopyrrolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of either sex aged 15-65 years Patient undergoing elective laparoscopic cholecystectomy American Society of Anesthesiologists (ASA) physical status I Exclusion Criteria: Patients with history of recent or past cardiac diseases Patients with pre-operative heart rate ≤60beats/min. Patients on cardiac medications Allergic to Glycopyrrolate

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycopyrrolate, Bradyarrhythmia, Laparoscopy, Pneumoperitoneum, Cardiac Arrest