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

November 1, 2018 updated by: Sameh Emile, Mansoura University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35516
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pyloric injection of magnesium sulfate and lidocaine mixture
After sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine
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
Active Comparator: Pyloric injection of saline
After sleeve gastrectomy, the pylorus is injected with normal saline
Procedure: Pyloric injection of saline
5 ml of normal saline is injected in the pylorus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: first 24 hours after surgery
incidence of postoperative nausea and vomiting as measured by special impact scale
first 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Sameh H Emile, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

November 1, 2018

First Submitted That Met QC Criteria

November 1, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mansoura66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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