Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy

NCT03180229 | Completed Phase 4

• 1 other identifier: Diskapi
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (3)

• change mean arterial blood pressure

  mean arterial blood pressure (MAP) MAP at least 25% less than the basal value

  Change from Baseline Systolic Blood Pressure at per 5 minute during surgery

• intubation quality

  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.

  intubation period

• change heart rate

  HR \<60 or \>25% drop baseline

  Change from baseline heart rate at per 5 minute during surgery

Study Arms (2)

Granisetron

ACTIVE COMPARATOR

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.

Drug: Granisetron 1 Mg/mL Intravenous Solution

Control

NO INTERVENTION

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.

Interventions

Granisetron 1 Mg/mL Intravenous Solution DRUG

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

Granisetron

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: 18-70
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparoscopic Cholecystectomy (lap) surgery

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 8, 2017
• Study Start: May 29, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 26, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

TU (1)