Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy

NCT ID: NCT03180229

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2018-12-26

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

Conditions

Cholelithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Granisetron

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.

Group Type: ACTIVE_COMPARATOR

Granisetron 1 Mg/mL Intravenous Solution

Intervention Type: DRUG

1 milligram (mg) will use on group Granisetron before 5 min induction

Control

Five minutes before the induction 1 ml saline iv use.Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Granisetron 1 Mg/mL Intravenous Solution

1 milligram (mg) will use on group Granisetron before 5 min induction

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Laparoscopic Cholecystectomy (lap) surgery

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Savas Altinsoy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Diskapi

Identifier Type: -

Identifier Source: org_study_id