Effect of Liberal and Restrictive Fluids on Nausea-vomiting

K

Karaman Training and Research Hospital

Status

Completed

Conditions

Postoperative Nausea and Vomiting

Treatments

Other: Liberal Fluid Grubu
Other: Restrictive Fluid Group

Study type

Interventional

Funder types

Other

Identifiers

NCT06197659
10-2023/14

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Muhammet Korkusuz

Data sourced from clinicaltrials.gov

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