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

NCT06847594 | Completed Phase 3 DMC

• 1 other identifier: FMASU MS129/2024
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Postoperative Nausea and Vomiting (PONV)

Keywords

postoperative nausea and vomiting; nausea; vomiting; laparoscopic cholecystectomy; superhydration; glucose 10%; dextrose 10%

Outcome Measures

Primary Outcomes (1)

• To compare the incidence of Post operative nausea and vomiting in the study treatment groups

  Postoperative 4 hours stay in PACU

Secondary Outcomes (4)

• Frequency of vomiting episodes

  Postoperative 4 hours stay in PACU

• Measurement of PONV severity scores

  Postoperative 4 hours stay in PACU

• Time from extubation till discharge from PACU

  From the moment of extubation till the moment of discharge from PACU with patient being completely vitally stable and nausea and vomiting free , assessed to be from 4 to 8 hours

• total antiemetic medication consumption

  Postoperative period 4 hours stay in PACU. ( if the patient needed to stay for longer duration in the PACU for any medical reason then any antiemetic used in this period will be recorded as well )

Study Arms (3)

Superhydration group receiving 20 ml/kg

ACTIVE COMPARATOR

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

Drug: ringer lactate (20ml/kg)

Dextrose group receiving Dextrose 10%

EXPERIMENTAL

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

Drug: Dextrose 10%

control group receiving 3ml/kg/hr

NO INTERVENTION

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

Interventions

ringer lactate (20ml/kg) DRUG

ringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively

Also known as: Superhydration

Superhydration group receiving 20 ml/kg

Dextrose 10% DRUG

Dextrose 10% 250 ml over 60 minutes

Dextrose group receiving Dextrose 10%

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 21- 60 years
• Patients with ASA classification I and II

You may not qualify if:

• Declining to give written informed consent.
• Patients with morbid obesity (BMI \> 40).
• ASA classification III-V.
• Sever hypertension and heart failure.
• Significant hepatic or renal disorder.
• Patients with diagnosed diabetes mellitus type 1 or type 2.
• Patients with history of PONV currently receiving steroids or antiemetics.
• Pregnant or menstruating patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, Abbassia, 11591, Egypt

Location

Related Publications (1)

• Stephenson SJ, Jiwanmall M, Cherian NE, Kamakshi S, Williams A. Reduction in post-operative nausea and vomiting (PONV) by preoperative risk stratification and adherence to a standardized anti emetic prophylaxis protocol in the day-care surgical population. J Family Med Prim Care. 2021 Feb;10(2):865-870. doi: 10.4103/jfmpc.jfmpc_1692_20. Epub 2021 Feb 27.

  PMID: 34041090 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Aya H. M. Ahmad, Assistant professor, MD

  Ain Shams University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Wael A. M. Abdelwahab, Assistant professor, MD

  Ain Shams University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Mohamed A. Elgendy, Assistant professor, MD

  Ain Shams University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 26, 2025
• Study Start: February 25, 2024
• Primary Completion: September 25, 2024
• Study Completion: October 10, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)