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NCT Number: NCT05620641

Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

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Key information

Conditions

Post Operative Nausea and Vomiting Body Weight Morbid Obesity Nausea Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Sleeve Gastrectomy Vomiting

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt

Tanta, Gharbia Governorate, 31111, Egypt

About this study

This study will be a double blind randomized, controlled, parallel, study. A total of1 00 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into two groups by closed envelop method,

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Both male and female patients will be included.
  • Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
  • Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
  • Patients fit for anesthesia and surgery.

Exclusion criteria

  • - Patients with BMI >55 kg/m2.
  • Patients with previous procedures for the treatment of obesity.
  • Pregnant females and lactating women.
  • Patients with psychological or psychiatric disease
  • Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
  • Patients who experienced vomiting within 24 hours before surgery.
  • Patients with history of alcohol or drug abuse.
  • Patients with hypersensitivity or contraindications to any of the drugs used in this study.

Treatment and study plan

Ondansetron 8mg

Drug

50 patients will receive intravenous ondansetron 8 mg before the end of surgery.

Other names: zofran

Gabapentin

Drug

50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.

Primary outcomes

  1. The primary outcome of this study will be the complete response within the first 48 h after surgery.

    Time frame: The first 48 hours after surgery.

    Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy

Secondary outcomes

  1. change in the level of the biological parameter vasopressin

    Time frame: The first 48 hours after surgery.

    5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of vasopressin

  2. change in the level of the biological parameter dopamine

    Time frame: The first 48 hours after surgery.

    5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of dopamine

  3. change in the level of the biological parameter substance p

    Time frame: The first 48 hours after surgery.

    5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of substance p

  4. change in the level of the biological parameter Serotonin

    Time frame: The first 48 hours after surgery.

    5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Serotonin

  5. change in the level of the biological parameter Tachykinin 1

    Time frame: The first 48 hours after surgery.

    5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Tachykinin 1

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2022
Registry last updated
Apr 17, 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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