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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03729505
Enrollment
70
Registered
2018-11-02
Start date
2017-07-01
Completion date
2018-08-30
Last updated
2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

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.

Interventions

PROCEDUREPyloric 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

PROCEDUREPyloric injection of saline

5 ml of normal saline is injected in the pylorus

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative nausea and vomitingfirst 24 hours after surgeryincidence of postoperative nausea and vomiting as measured by special impact scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026