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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting (PONV)
• Intervention / Treatment: Drug: ringer lactate (20ml/kg); Drug: Dextrose 10%

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 11591
      • Faculty of Medicine Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Superhydration group receiving 20 ml/kg; Group Ringer Lactate planned to receive ringer lactate 20 ml/kg over the first 90 to 120 minutes	Drug: ringer lactate (20ml/kg); ringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively; Other Names: Superhydration
Experimental: 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	Drug: Dextrose 10%; Dextrose 10% 250 ml over 60 minutes
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the incidence of Post operative nausea and vomiting in the study treatment groups	Postoperative 4 hours stay in PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of vomiting episodes		Postoperative 4 hours stay in PACU
Measurement of PONV severity scores	Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of: Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment. Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment. PONV scores were obtained every half hour	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	Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of: Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment. Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment. PONV scores were obtained every half hour, Rescue antiemetic granisetron 1 mg IV was given when VDS scores were 2 or more. Medications were given only after excluding other causes of PONV such as hypovolemia, hypotension, hypoxia. The total number of doses of antiemetics used were obtained every half hour from the time of entry to the PACU for 4 hours	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 )

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: 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; Study Director: Mohamed A. Elgendy, Assistant professor, MD, Ain Shams University Faculty of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Actual): September 25, 2024
• Study Completion (Actual): October 10, 2024

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: nausea; vomiting; laparoscopic cholecystectomy; postoperative nausea and vomiting; glucose 10%; superhydration; dextrose 10%
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: FMASU MS129/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD that will be shared will be Age, Sex, BMI, ASA score , operation duration and anesthesia duration , PONV severity score, nausea and vomiting frequency , total antiemetic usage intra and postoperative in the PACU and time needed to discharge from the PACU
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No