Effect of Liberal and Restrictive Fluids on Nausea-vomiting

Postoperative Nausea and Vomiting Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06197659
• Other study ID #: 10-2023/14
• Status: Completed
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: Karaman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 15, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Turkey	Karaman Taining and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to first antiemetic request	Time to first antiemetic request within 24 hours after surgery	Postoperative 24 hours
Secondary	Time to request first oral drink	Time to request first oral drink within 24 hours after surgery	Postoperative 24 hours
Secondary	First mobilization time	First mobilization time after surgery	Postoperative 24 hours
Secondary	Total amount of analgesic	Total amount of rescue analgesic (tramadol) in the 24 hours after surgery	Postoperative 24 hours