Skip to main content
OpenTrials
Completed

NCT Number: NCT06197659

Effect of Liberal and Restrictive Fluids on Nausea-vomiting

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liberal Fluid Grubu

Other

Patients in this group will be administered 20 mL/kg/h ringer lactate intravenously peroperatively.

Other names: Liberal group

Restrictive Fluid Group

Other

Patients in this group will be administered 4 mL/kg/h ringer lactate intravenously peroperatively.

Other names: Restrictive group

Primary outcomes

  1. Incidence of postoperative nausea-vomiting

    Time frame: 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.

  2. Quality of recovery

    Time frame: 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 outcomes

  1. Time to first antiemetic request

    Time frame: Postoperative 24 hours

    Time to first antiemetic request within 24 hours after surgery

  2. Time to request first oral drink

    Time frame: Postoperative 24 hours

    Time to request first oral drink within 24 hours after surgery

  3. First mobilization time

    Time frame: Postoperative 24 hours

    First mobilization time after surgery

  4. Total amount of analgesic

    Time frame: Postoperative 24 hours

    Total amount of rescue analgesic (tramadol) in the 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.