Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2025-02-28

Brief Summary

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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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Detailed Description

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. 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

Conditions

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Postoperative Nausea and Vomiting Laparoscopic Sleeve Gastrectomy Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

double blind

Study Groups

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Group 1(Control group)

include 50 patients scheduled for sleeve gastrectomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

which include 50 patients scheduled for sleeve gastrectomy

Group Type EXPERIMENTAL

Baclofen Tablets

Intervention Type DRUG

10 mg oral baclofen 1 h before anesthesia

Interventions

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Baclofen Tablets

10 mg oral baclofen 1 h before anesthesia

Intervention Type DRUG

Other Intervention Names

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baclofen

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes