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

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ClinicalTrials.gov Identifier: NCT03729505
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Pyloric injection of magnesium sulfate and lidocaine mixture Procedure: Pyloric injection of saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Pyloric Injection With Magnesium Sulphate and Lidocaine Mixture on Early Postoperative Outcome After Laparoscopic Sleeve Gastrectomy
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : August 30, 2018

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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




Primary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: first 24 hours after surgery ]
    incidence of postoperative nausea and vomiting as measured by special impact scale



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729505


Locations
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Egypt
Mansoura university hospital
Mansourah, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Sameh H Emile Mansoura University
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Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT03729505    
Other Study ID Numbers: mansoura66
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Lidocaine
Magnesium Sulfate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anticonvulsants
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents