An Evaluation the Effect of Superhydration Versus Dextrose 10% for Prevention of Post Operative Nausea and Vomiting After Laparoscopic Cholecystectomy (prospective Randomised Controlled Study)

Last updated: February 21, 2025
Sponsor: Ain Shams University
Overall Status: Completed

Phase

3

Condition

Colic

Vomiting

Lactose Intolerance

Treatment

Dextrose 10%

ringer lactate (20ml/kg)

Clinical Study ID

NCT06847594
FMASU MS129/2024
  • Ages 21-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to learn if Dextrose 10% or superhydration works to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

. The main questions it aims to answer are:

Does Dextrose 10% or superhydration lower the number of times participants gets an episode of nausea and vomititng after laparoscopic cholecystectomy surgery? Researchers will compare Dextrose 10% versus superhydration to a placebo (a look-alike substance that contains no drug) to see if glucose 10% or superhydation can work to prevent postoperative nausea and vomiting.

Participants will:

Take Dextrose 10% or superhydration or a placebo in the operation monitored for 4 hours after surgery to check on their nausea and vomiting state

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: 21- 60 years

  2. Patients with ASA classification I and II

Exclusion

Exclusion Criteria:

  1. Declining to give written informed consent.

  2. Patients with morbid obesity (BMI > 40).

  3. ASA classification III-V.

  4. Sever hypertension and heart failure.

  5. Significant hepatic or renal disorder.

  6. Patients with diagnosed diabetes mellitus type 1 or type 2.

  7. Patients with history of PONV currently receiving steroids or antiemetics.

  8. Pregnant or menstruating patients.

Study Design

Total Participants: 204
Treatment Group(s): 2
Primary Treatment: Dextrose 10%
Phase: 3
Study Start date:
February 25, 2024
Estimated Completion Date:
October 10, 2024

Connect with a study center

  • Faculty of Medicine Ain Shams University

    Cairo, Abbassia 11591
    Egypt

    Site Not Available

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