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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | 31 participants received 1ml of Normal Saline |
|
| Glyco | Experimental | 31 participants received 1ml (0.2mg) of Glycopyrrolate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | After surgical creation of umbilical port Control group received injection normal saline 1ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate (Bradycardia) | The primary outcome will be Bradycardia defined as heart rate below 60beats per minute | 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 | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Monitoring of systolic Blood pressure | 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) |
| Diastolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brihaspati K C, MD | NAMS Bir Hospital | Principal Investigator |
| Brahmadev Jha, MD | NAMS Bir Hospital | Study Chair |
| Surendra Bhusal, MD | NAMS Bir Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Academy of Medical Sciences | Kathmandu | Nepal |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D006323 | Heart Arrest |
| D013610 | Tachycardia |
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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.
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| Glycopyrrolate | Drug | After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg |
|
Monitoring of diastolic Blood pressure |
| 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) |
| Mean Arterial Pressure | Monitoring of Mean Arteria pressure | 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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D000644 |
| Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |