- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03355807
Use of MgSO4 for Pain After Bariatric Surgery
Use of MgSO4 Reduced Opioid Consumption for Pain After Sleeve Gastrectomy Operations: A Prospective Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this study is to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation.
Design: A prospective, randomized, controlled clinical study.
Setting: University hospital.
Participants: Eighty patients undergoing sleeve gastrectomy.
Measurements and Main Results: Visual analog scale for pain score, sedation score, mean arterial pressure, heart rate, and valid and invalid analgesic demand will record. Serum magnesium levels will determined at preoperative evaluation, postanesthesia care unit admission and at 24 hours. Side effects will also record.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 to 65 year old individuals who underwent laparoscopic sleeve gastrectomy.
Exclusion Criteria:
- One or more of the following: cardio - vascular and respiratory diseases, drug and/or alcohol abuse, use of daily an algesia 24 hours before the surgery, renal failure, and liver dysfunction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group MgSO4
The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4 (30 mg/kg by bolus and 10 mg/kg/h by infusion for 24 hours)
|
The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4
|
NO_INTERVENTION: Group Control
the control group (group C, n _ 40) received the same amount of IV saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Item pain intensity measure assessed by using VAS scores
Time Frame: 1 day
|
Pain was assessed by using VAS scores (0: no pain and 10: worst pain) imaginable recorded at 0, 1, 2, 4, 6, 24, and 24 hours.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: nurcan kizilcik, MD, yeditepe universityiversity
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- obesity (magnesium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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