Impact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Pyloric injection of magnesium sulfate and lidocaine mixture; Procedure: Pyloric injection of saline

• Registration Number: NCT03729505
• Lead Sponsor: Mansoura University

Brief Summary

Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly due to increased intragastric pressure. The present trial aimed to assess the effect of pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric intraluminal pressure and incidence of nausea and vomiting.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-07-30
• Study Completion: 2018-08-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-01
• Last Update Submitted: 2018-11-01
• Study First Posted: 2018-11-02
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients that aged between18 and 65 years.
• American Society of Anesthesiologists (ASA) class I - III.
• Morbidly-obese patients who failed to achieve and maintain a clinically significant weight loss through supervised non-surgical methods for at least 6 months.
• Surgery was conducted as the first line of treatment in case of patients with BMI ≥ 50 kg/m2 (super obese).

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Exclusion Criteria

• Obesity secondary to endocrine disorders.
• History of any previous bariatric procedure.
• Impaired intellectual capacity or major psyciatric disorder.
• Sweet eaters who would not adopt a change of postoperative eating habits.
• Lack of willingness and motivation to embrace postoperative lifestyle changes.
• Substance abuse.
• Pregnancy or expected pregnancy in the following 12 to 18 months.
• Severe gastroesophageal reflux disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pyloric injection of magnesium sulfate and lidocaine mixture	Pyloric injection of magnesium sulfate and lidocaine mixture	After sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine
Pyloric injection of saline	Pyloric injection of saline	After sleeve gastrectomy, the pylorus is injected with normal saline

Primary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	first 24 hours after surgery	incidence of postoperative nausea and vomiting as measured by special impact scale

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt