Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
Condition: Bradyarrhythmia; Cardiac Arrest; Tachycardia; Asystole
MeSH terms: Heart Arrest; Tachycardia; Bradycardia
Study type: Interventional

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.
    

Intervention name(s): Normal Saline; Glycopyrrolate
Intervention type(s): Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Glycopyrrolate
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Glycopyrrolate; Bradyarrhythmia; Laparoscopy; Pneumoperitoneum; Cardiac Arrest