Effect of Liberal and Restrictive Fluids on Nausea-vomiting

NCT06197659 | Completed

• 1 other identifier: 10-2023/14
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to first antiemetic request

  Postoperative 24 hours

• Time to request first oral drink

  Postoperative 24 hours

• First mobilization time

  Postoperative 24 hours

• Total amount of analgesic

  Postoperative 24 hours

Study Arms (2)

Liberal Fluid Group

ACTIVE COMPARATOR

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

Other: Liberal Fluid Grubu

Restrictive Fluid Group

SHAM COMPARATOR

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

Other: Restrictive Fluid Group

Interventions

Liberal Fluid Grubu OTHER

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

Also known as: Liberal group

Liberal Fluid Group

Restrictive Fluid Group OTHER

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

Also known as: Restrictive group

Restrictive Fluid Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for laparoscopic cholecystectomy
• Patients aged 18-70

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Taining and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Muhammet Korkusuz

  Karamanoglu Mehmetbey University, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: patients, care providers, and outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 9, 2024
• Study Start: January 1, 2024
• Primary Completion: February 10, 2024
• Study Completion: February 15, 2024
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

TU (1)