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Completed

NCT Number: NCT05997004

Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

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?

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Key information

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Academy of Medical Sciences

Kathmandu, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

After surgical creation of umbilical port Control group received injection normal saline 1ml.

Glycopyrrolate

Drug

After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg

Primary outcomes

  1. Heart Rate (Bradycardia)

    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

Secondary outcomes

  1. 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 systolic Blood pressure

  2. 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 diastolic Blood pressure

  3. Mean Arterial 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

Sponsors and collaborators

Lead sponsor

National Academy of Medical Sciences, Nepal

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2023
Registry last updated
Aug 28, 2023

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.

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