Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy (lap)

Diskapi Yildirim Beyazit Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Cholelithiasis

Treatments: Drug: Granisetron 1 Mg/mL Intravenous Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03180229

Diskapi

Details and patient eligibility

About

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

Full 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

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Laparoscopic Cholecystectomy (lap) surgery

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

140 participants in 2 patient groups

Granisetron

Active Comparator group

Description:

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.

Treatment:

Drug: Granisetron 1 Mg/mL Intravenous Solution

Control

No Intervention group

Description:

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.