National Academy of Medical Sciences
Kathmandu, Nepal
NCT Number: NCT05997004
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?
Looking for future studies?
Notify Me15 year–65 year
All sexes
Interventional
Not applicable
Kathmandu, Nepal
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After surgical creation of umbilical port Control group received injection normal saline 1ml.
After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
National Academy of Medical Sciences, Nepal
Other Gov
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04831125
Arrhythmias, Cardiac, Bradyarrhythmia
Tucson, Arizona, United States
View Trial DetailsNCT01513538
Arrhythmias, Cardiac, Bradyarrhythmia
Marseille, France
View Trial DetailsNCT01522755
Arrhythmias, Cardiac, Bradyarrhythmia
Orléans, France
View Trial DetailsNCT06977789
Arrhythmias, Cardiac, Arrythmia
Singapore
View Trial Details