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Completed

NCT Number: NCT03729505

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

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 saline

Procedure

5 ml of normal saline is injected in the pylorus

Primary outcomes

  1. Postoperative nausea and vomiting

    Time frame: first 24 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2018
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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