Effect of Liberal and Restrictive Fluids on Nausea-vomiting

The Effect of Peroperative Restrictive and Liberal Fluid Regimens on Postoperative Nausea-vomiting and Quality of Recovery in Laparoscopic Cholecystectomy: a Prospective Randomized Study.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: Liberal Fluid Grubu; Other: Restrictive Fluid Group

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammet Korkusuz; Phone Number: +905056776497; Email: drmuhammetkorkusuz@gmail.com

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Taining and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liberal Fluid Group; Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.	Other: Liberal Fluid Grubu; Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.; Other Names: Liberal group
Sham Comparator: Restrictive Fluid Group; Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.	Other: Restrictive Fluid Group; Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.; Other Names: Restrictive group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea-vomiting	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.	Postoperative 24 hours
Quality of recovery	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.	Postoperative 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Principal Investigator: Muhammet Korkusuz, Karamanoglu Mehmetbey University, School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): February 10, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 10-2023/14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No