Clinical trial NCT05997004: Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
Official title: Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradyarrhythmia
Cardiac Arrest
Tachycardia
Asystole
Keywords: Glycopyrrolate
Bradyarrhythmia
Laparoscopy
Pneumoperitoneum
Cardiac Arrest
Lead sponsor: National Academy of Medical Sciences, Nepal
Sponsor class: OTHER_GOV
First posted: 2023-08-18
Enrollment: 62
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Heart Rate (Bradycardia)
timeFrame: 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 outcomes:
measure: Systolic Blood Pressure
timeFrame: 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)
measure: Diastolic Blood Pressure
timeFrame: 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)
measure: Mean Arterial Pressure
timeFrame: 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)
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: National Academy of Medical Sciences
Study officials:
affiliation: NAMS Bir Hospital
name: Brihaspati K C, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NAMS Bir Hospital
name: Brahmadev Jha, MD
role: STUDY_CHAIR
affiliation: NAMS Bir Hospital
name: Surendra Bhusal, MD
role: STUDY_CHAIR
References: