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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?


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05997004
Study type Interventional
Source National Academy of Medical Sciences, Nepal
Contact
Status Completed
Phase N/A
Start date May 1, 2018
Completion date November 15, 2019

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