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NCT Number: 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)

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

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Key information

Conditions

Postoperative Nausea and Vomiting (PONV) Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine Ain Shams University

Cairo, Abbassia, 11591, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

ringer lactate (20ml/kg)

Drug

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

Other names: Superhydration

Dextrose 10%

Drug

Dextrose 10% 250 ml over 60 minutes

Primary outcomes

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

    Time frame: Postoperative 4 hours stay in PACU

Secondary outcomes

  1. Frequency of vomiting episodes

    Time frame: Postoperative 4 hours stay in PACU

  2. Measurement of PONV severity scores

    Time frame: Postoperative 4 hours stay in PACU

    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

  3. Time from extubation till discharge from PACU

    Time frame: 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

  4. total antiemetic medication consumption

    Time frame: 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 )

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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