Back to resultsImpact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pyloric injection of magnesium sulfate and lidocaine mixture
Pyloric injection of saline
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pyloric injection of magnesium sulfate and lidocaine mixture
Pyloric injection of saline
Arm Description
After sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine
After sleeve gastrectomy, the pylorus is injected with normal saline
Outcomes
Primary Outcome Measures
Postoperative nausea and vomiting
incidence of postoperative nausea and vomiting as measured by special impact scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03729505
Brief Title
Impact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy
Official Title
Impact of Pyloric Injection With Magnesium Sulphate and Lidocaine Mixture on Early Postoperative Outcome After Laparoscopic Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pyloric injection of magnesium sulfate and lidocaine mixture
Arm Type
Active Comparator
Arm Description
After sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine
Arm Title
Pyloric injection of saline
Arm Type
Active Comparator
Arm Description
After sleeve gastrectomy, the pylorus is injected with normal saline
Intervention Type
Procedure
Intervention Name(s)
Pyloric injection of magnesium sulfate and lidocaine mixture
Intervention Description
100 mg / 2 ml of magnesium sulphate (Magnesium Sulfate®) is mixed with 5 ml of 2% lidocaine and injected in the pylorus
Intervention Type
Procedure
Intervention Name(s)
Pyloric injection of saline
Intervention Description
5 ml of normal saline is injected in the pylorus
Primary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
incidence of postoperative nausea and vomiting as measured by special impact scale
Time Frame
first 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Impact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy
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