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

Morbid Obesity Clinical Trial

Official title:

Impact of Pyloric Injection With Magnesium Sulphate and Lidocaine Mixture on Early Postoperative Outcome After Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729505
• Other study ID #: mansoura66
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: November 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• 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
• Pyloric injection of saline
5 ml of normal saline is injected in the pylorus

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative nausea and vomiting	incidence of postoperative nausea and vomiting as measured by special impact scale	first 24 hours after surgery