Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy

Phase 4

Completed

• Conditions: Cholelithiasis
• Interventions: Drug: Granisetron 1 Mg/mL Intravenous Solution

• Registration Number: NCT03180229
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary

Propofol is one of the most commonly used anesthetic agents because of its ability to induce rapid and reliable collection. However, hypotension and injection pain in the induction are the most common complications. After induction of propofol; The cardiovascular system depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic vascular resistance. This may also contribute to the reduction of sympathetic tone activity in the central way, and slight reduction in the number of pulses that develop as a result of increasing vagal activity. İn order to attenuate these hemodynamic undesired effects caused by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer lactate, ketamine. Ondansetron and granisetron, which are used for postoperative nausea and vomiting prophylaxis, have been used as such. Therefore, ondansetron and granisetron were preventing hypotension induced by post-spinal and general anesthesia induction.

The investigator also tried to demonstrate the effect of granisetron, another serotonin type 3 (5-HT3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction hypotension and intubation quality after propofol induction in this study

Detailed Description

150 participants with American Society of Anesthesiologists (ASA) physical score I-II who underwent elective laparoscopic cholecystectomy between the ages of 18-70 will be enrolled. Participants will be divided into two groups using granisetron and control.

All participants will be premedicated with 0.05 mg kg-1 midazolam 30 minutes before the operation. ASA, age, sex, weight demographic data of the participants who were taken to the operating room will record. Peripheral oxygen saturation (SPO2), noninvasive blood pressure and electrocardiography (ECG) will monitored. A venous cannula will place on the back of the hand. Participants will randomly divide into 2 groups by closed envelope method.

Five minutes before the induction of group G, 1 ml (1 mg / ml) iv granisetron, group K will receive 1 ml saline. Propofol at induction will be administered at a dose of 0.6 mg / kg of rocuronium at a dose of 2 mg / kg. Pre-induction, post-intubation and every five minutes SPO2, diastolic arterial pressure (DAP), mean arterial pressure (MAP), systolic arterial pressure(SAP) and heart rate (HR) will record. Intubation quality will be evaluated by evans score.

Systolic Blood Pressure \<Control + 15 0 \<Control + 30 1 1

* Control + 30 2 Heart Rate Pressure \<Control + 15 0 \<Control + 30 1

* Control + 30 2 Sweating No 0 Moist leather 1 Visible sweating 2 Tears No 0 Yes 1 Overflowing 2

Study Timeline

• Study Start: 2017-05-29
• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-08
• Primary Completion: 2017-09-01
• Study Completion: 2018-12-26
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Laparoscopic Cholecystectomy (lap) surgery

Exclusion Criteria

• Acute pancreatitis disease
• Cardiorespiratory disease
• Hypertension
• Anti hypertension treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Granisetron	Granisetron 1 Mg/mL Intravenous Solution	Five minutes before the induction 1 ml (1 mg / ml) iv granisetron will use. .Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery.

Primary Outcome Measures

Name	Time	Method
change mean arterial blood pressure	Change from Baseline Systolic Blood Pressure at per 5 minute during surgery	mean arterial blood pressure (MAP) MAP at least 25% less than the basal value
intubation quality	intubation period	in this time evans score which is included tears, sweating, systolic arterial blood pressure and heart rate will be used. the change baseline systolic arterial blood pressure and heart rate and tears, sweating will score numeric.
change heart rate	Change from baseline heart rate at per 5 minute during surgery	HR \<60 or \>25% drop baseline

Trial Locations

Locations (1)

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey; 🇹🇷 Ankara, Turkey