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NCT Number: NCT05516953

Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Tanta, 31111, Egypt

About this study

. A total of 100 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 four 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

  • 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

Baclofen Tablets

Drug

10 mg oral baclofen 1 h before anesthesia

Other names: baclofen

Primary outcomes

  1. The primary outcome of this study will be the complete response

    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 serum level of vasopressin

    Time frame: The first 48 hours after surgery.

    Blood samples will be collected at baseline, 24 hours and 48 hours after surgery

  2. Change in serum level of substance P

    Time frame: The first 48 hours after surgery.

    Blood samples will be collected at baseline, 24 hours and 48 hours after surgery

  3. Change in serum level of dopamine

    Time frame: The first 48 hours after surgery.

    Blood samples will be collected at baseline, 24 hours and 48 hours after surgery

  4. Change in serum level of serotonin

    Time frame: The first 48 hours after surgery.

    Blood samples will be collected at baseline, 24 hours and 48 hours after surgery

  5. Change in serum level of tachykinin 1

    Time frame: The first 48 hours after surgery.

    Blood samples will be collected at baseline, 24 hours and 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 26, 2022
Registry last updated
Apr 22, 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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