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

NCT03729505 | Completed

• 1 other identifier: mansoura66
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting

  incidence of postoperative nausea and vomiting as measured by special impact scale

  first 24 hours after surgery

Study Arms (2)

Pyloric injection of magnesium sulfate and lidocaine mixture

ACTIVE COMPARATOR

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

Procedure: Pyloric injection of magnesium sulfate and lidocaine mixture

Pyloric injection of saline

ACTIVE COMPARATOR

After sleeve gastrectomy, the pylorus is injected with normal saline

Procedure: Pyloric injection of saline

Interventions

Pyloric injection of magnesium sulfate and lidocaine mixture 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 magnesium sulfate and lidocaine mixture

Pyloric injection of saline PROCEDURE

5 ml of normal saline is injected in the pylorus

Pyloric injection of saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sameh H Emile

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of general surgery

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 2, 2018
• Study Start: July 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: August 30, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-11

Locations

EG (1)