An Evaluation the Effect of Superhydration Versus Dextrose 10% for Prevention of Post Operative Nausea and Vomiting After Laparoscopic Cholecystectomy (prospective Randomised Controlled Study)
NCT ID: NCT06847594
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2024-02-25
2024-10-10
Brief Summary
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. 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Superhydration group receiving 20 ml/kg
Group Ringer Lactate planned to receive ringer lactate 20 ml/kg over the first 90 to 120 minutes
ringer lactate (20ml/kg)
ringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively
Dextrose group receiving Dextrose 10%
Group Dextrose planned to receive Dextrose 10% 250 ml over 60 minutes added to 3 ml/kg/Hr ringer lactate as intraoperative fluid maintenance
Dextrose 10%
Dextrose 10% 250 ml over 60 minutes
control group receiving 3ml/kg/hr
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
No interventions assigned to this group
Interventions
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ringer lactate (20ml/kg)
ringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively
Dextrose 10%
Dextrose 10% 250 ml over 60 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with ASA classification I and II
Exclusion Criteria
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.
21 Years
60 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Aya H. M. Ahmad, Assistant professor, MD
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University Faculty of Medicine
Wael A. M. Abdelwahab, Assistant professor, MD
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University Faculty of Medicine
Mohamed A. Elgendy, Assistant professor, MD
Role: STUDY_DIRECTOR
Ain Shams University Faculty of Medicine
Locations
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Faculty of Medicine Ain Shams University
Cairo, Abbassia, Egypt
Countries
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References
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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.
Other Identifiers
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FMASU MS129/2024
Identifier Type: -
Identifier Source: org_study_id
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