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

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Postoperative Nausea and Vomiting (PONV)

Treatments: Drug: ringer lactate (20ml/kg); Drug: Dextrose 10%

Study type: Interventional

Funder types: Other

Identifiers

NCT06847594

FMASU MS129/2024

Details and patient eligibility

About

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

Enrollment: 204 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: 21- 60 years
2. Patients with ASA classification I and II

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 3 patient groups

Superhydration group receiving 20 ml/kg

Active Comparator group

Description:

Group Ringer Lactate planned to receive ringer lactate 20 ml/kg over the first 90 to 120 minutes

Treatment:

Drug: ringer lactate (20ml/kg)

Dextrose group receiving Dextrose 10%

Experimental group

Description:

Group Dextrose planned to receive Dextrose 10% 250 ml over 60 minutes added to 3 ml/kg/Hr ringer lactate as intraoperative fluid maintenance

Treatment:

Drug: Dextrose 10%

control group receiving 3ml/kg/hr

No Intervention group

Description:

Group control planned to receive ringer lactate with rate 3ml /kg /Hr as intraoperative fluid maintenance added to the loading dose according to Ain Shams Anesthesia and Critical care department protocol