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

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

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-08-30

Brief Summary

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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.

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Gynecologic Disease

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Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Pyloric injection of magnesium sulfate and lidocaine mixture

After sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine

Group Type ACTIVE_COMPARATOR

Pyloric injection of magnesium sulfate and lidocaine mixture

Intervention Type PROCEDURE

100 mg / 2 ml of magnesium sulphate (Magnesium Sulfate®) is mixed with 5 ml of 2% lidocaine and injected in the pylorus

Pyloric injection of saline

After sleeve gastrectomy, the pylorus is injected with normal saline

Group Type ACTIVE_COMPARATOR

Pyloric injection of saline

Intervention Type PROCEDURE

5 ml of normal saline is injected in the pylorus

Interventions

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Pyloric injection of magnesium sulfate and lidocaine mixture

100 mg / 2 ml of magnesium sulphate (Magnesium Sulfate®) is mixed with 5 ml of 2% lidocaine and injected in the pylorus

Intervention Type PROCEDURE

Pyloric injection of saline

5 ml of normal saline is injected in the pylorus

Intervention Type PROCEDURE

Eligibility Criteria

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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).

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No