Clinical trial NCT06197659: Effect of Liberal and Restrictive Fluids on Nausea-vomiting
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
Laparoscopic Cholecystectomy
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two group;

1. Experimental Group: Group L; Liberal Fluid Group; Peroperative 20 mL/kg/h intravenous ringer lactate will be administered.
2. Sham Comparator: Group R; Restrictive Fluid Group; Peroperative 5 mL/kg/h intravenous ringer lactate will be administered.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative nausea-vomiting
timeFrame: Postoperative 24 hours
measure: Quality of recovery
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Time to first antiemetic request
timeFrame: Postoperative 24 hours
measure: Time to request first oral drink
timeFrame: Postoperative 24 hours
measure: First mobilization time
timeFrame: Postoperative 24 hours
measure: Total amount of analgesic
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Taining and Research Hospital
Study officials:
affiliation: Karamanoglu Mehmetbey University, School of Medicine
name: Muhammet Korkusuz
role: PRINCIPAL_INVESTIGATOR
References: