Clinical trial NCT06847594: An Evaluation the Effect of Superhydration Versus Dextrose 10% for Prevention of Post Operative Nausea and Vomiting After Laparoscopic Cholecystectomy (prospective Randomised Controlled Study)
Official title: Superhydration Versus Dextrose 10% for Prevention of Post Operative Nausea and Vomiting After Laparoscopic Cholecystectomy (prospective Randomised Controlled Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting (PONV)
Keywords: postoperative nausea and vomiting
nausea
vomiting
laparoscopic cholecystectomy
superhydration
glucose 10%
dextrose 10%
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 204
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: To compare the incidence of Post operative nausea and vomiting in the study treatment groups
timeFrame: Postoperative 4 hours stay in PACU
Secondary outcomes:
measure: Frequency of vomiting episodes
timeFrame: Postoperative 4 hours stay in PACU
measure: Measurement of PONV severity scores
timeFrame: Postoperative 4 hours stay in PACU
measure: Time from extubation till discharge from PACU
timeFrame: 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
measure: total antiemetic medication consumption
timeFrame: 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 )
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University
state: Abbassia
Study officials:
affiliation: Ain Shams University Faculty of Medicine
name: Aya H. M. Ahmad, Assistant professor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University Faculty of Medicine
name: Wael A. M. Abdelwahab, Assistant professor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University Faculty of Medicine
name: Mohamed A. Elgendy, Assistant professor, MD
role: STUDY_DIRECTOR
References:
citation: 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.