NCT05516953

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

August 24, 2022

Last Update Submit

April 18, 2025

Conditions

Postoperative Nausea and VomitingLaparoscopic Sleeve GastrectomyMorbid Obesity

Keywords

Postoperative Nausea and VomitingLaparoscopic Sleeve GastrectomybaclofenMorbid Obesity

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of this study will be the complete response

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

    The first 48 hours after surgery.

Secondary Outcomes (5)

  • Change in serum level of vasopressin

    The first 48 hours after surgery.

  • Change in serum level of substance P

    The first 48 hours after surgery.

  • Change in serum level of dopamine

    The first 48 hours after surgery.

  • Change in serum level of serotonin

    The first 48 hours after surgery.

  • Change in serum level of tachykinin 1

    The first 48 hours after surgery.

Study Arms (2)

Group 1(Control group)

NO INTERVENTION

include 50 patients scheduled for sleeve gastrectomy

Group 2

EXPERIMENTAL

which include 50 patients scheduled for sleeve gastrectomy

Drug: Baclofen Tablets

Interventions

Baclofen TabletsDRUG

10 mg oral baclofen 1 h before anesthesia

Also known as: baclofen
Group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tanta, 31111, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and VomitingObesity, Morbid

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomitingObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Aya Moussa

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at Clinical Pharmacy department , Faculty of Pharmacy -Tanta University

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

August 22, 2022

Primary Completion

December 28, 2024

Study Completion

February 28, 2025

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)