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

Mansoura University

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: Pyloric injection of magnesium sulfate and lidocaine mixture; Procedure: Pyloric injection of saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03729505

mansoura66

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Pyloric injection of magnesium sulfate and lidocaine mixture

Active Comparator group

Description:

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

Treatment:

Procedure: Pyloric injection of magnesium sulfate and lidocaine mixture

Pyloric injection of saline

Active Comparator group

Description:

After sleeve gastrectomy, the pylorus is injected with normal saline

Treatment:

Procedure: Pyloric injection of saline