Effect of Liberal and Restrictive Fluids on Nausea-vomiting

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Other: Liberal Fluid Grubu; Other: Restrictive Fluid Group

• Registration Number: NCT06197659
• Lead Sponsor: Karaman Training and Research Hospital

Brief Summary

Patients planned for laparoscopic cholecystectomy will be included in this study. The effects of liberal and restrictive fluid regimens given peroperatively to patients undergoing laparoscopic cholecystectomy will be compared on postoperative nausea and vomiting. The aim of this study is to investigate which regimen is more effective on postoperative nausea and vomiting in laparoscopic cholecystectomy.

Detailed Description

Postoperative nausea and vomiting (PONV) is a common and disturbing side effect of anesthesia and surgery, and while its incidence in all surgical procedures varies between 20-77% if antiemetic prophylaxis is not applied, this rate is even higher in people prone to vomiting, such as cyclic vomiting syndrome . Its incidence varies between 53 - 72%, especially in patients undergoing laparoscopic cholecystectomy surgery, if antiemetic prophylaxis is not administered.

Since most existing antiemetics are expensive and cannot completely eliminate PONV, pharmacological PONV prophylaxis may not be cost-effective. For this reason, the incidence of PONV can be reduced by increasing the amount of inexpensive fluid used during surgery instead of prophylactic drug treatment. There are several studies investigating the effect of different perioperative fluid administration schemes on PONV in the adult population, especially in patients undergoing laparoscopic cholecystectomy or gynecological surgery, with variable results.

Based on this point, the inestigetors wanted to examine the effect of perioperative liberal and restrictive fluid treatments on PONV in patients who underwent laparoscopic cholecystectomy.

Study Timeline

• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-26
• Study Start: 2024-01-01
• Study First Posted: 2024-01-09
• Status Verified: 2024-02
• Primary Completion: 2024-02-10
• Study Completion: 2024-02-15
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients planned for laparoscopic cholecystectomy
• Patients aged 18-70

Exclusion Criteria

• Congestive heart failure.
• Diabetes.
• Epilepsy.
• Heart valve disease.
• They are pregnant.
• Chronic liver disease.
• Chronic kidney disease. Chronic gastrointestinal tract disease. Those who used antiemetic drugs within 24 hours before surgery. Those who developed intraoperative hypertension. Those who develop excessive blood loss. Patients whose surgery procedure takes more than 2 hours.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal Fluid Group	Liberal Fluid Grubu	Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.
Restrictive Fluid Group	Restrictive Fluid Group	Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea-vomiting	Postoperative 24 hours	Incidence of nausea and vomiting within 24 hours after surgery. The presence of at least one episode of nausea, retching and vomiting in the first 24 hours postoperatively will be considered a positive result.
Quality of recovery	Postoperative 24 hours	Quality of recovery will be evaluated at the 24th hour using the QoR-15 scale. It is a scale consisting of 15 questions and scoring from 0 to 10 for each question. 0 represents the worst and 150 represents the best recovery quality.

Secondary Outcome Measures

Name	Time	Method
Time to first antiemetic request	Postoperative 24 hours	Time to first antiemetic request within 24 hours after surgery
Time to request first oral drink	Postoperative 24 hours	Time to request first oral drink within 24 hours after surgery
Total amount of analgesic	Postoperative 24 hours	Total amount of rescue analgesic (tramadol) in the 24 hours after surgery
First mobilization time	Postoperative 24 hours	First mobilization time after surgery

Trial Locations

Locations (1)

Karaman Taining and Research Hospital; 🇹🇷 Karaman, Turkey