Back to resultsUse of MgSO4 for Pain After Bariatric Surgery
Primary Purpose
Therapeutic Opioid Induced Constipation (Disorder)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium
Sponsored by
About this trial
This is an interventional other trial for Therapeutic Opioid Induced Constipation (Disorder) focused on measuring sleeve gastrectomy, magnesium sulfate, postoperative pain, bariatric surgery
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group MgSO4
Group Control
Arm Description
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 control group (group C, n _ 40) received the same amount of IV saline
Outcomes
Primary Outcome Measures
Item pain intensity measure assessed by using VAS scores
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03355807
First Posted
September 28, 2017
Last Updated
May 21, 2018
Sponsor
Yeditepe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03355807
Brief Title
Use of MgSO4 for Pain After Bariatric Surgery
Official Title
Use of MgSO4 Reduced Opioid Consumption for Pain After Sleeve Gastrectomy Operations: A Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutic Opioid Induced Constipation (Disorder)
Keywords
sleeve gastrectomy, magnesium sulfate, postoperative pain, bariatric surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients undergoing sleeve gastrectomy.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A Patient, investigator and anesthesiologist who was blinded to the assignment of the patients recorded levels of sedation, pain, cumulative morphine consumption, and hemodynamic variables
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group MgSO4
Arm Type
Experimental
Arm Description
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)
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
the control group (group C, n _ 40) received the same amount of IV saline
Intervention Type
Drug
Intervention Name(s)
Magnesium
Intervention Description
The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4
Primary Outcome Measure Information:
Title
Item pain intensity measure assessed by using VAS scores
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nurcan kizilcik, MD
Organizational Affiliation
yeditepe universityiversity
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24431032
Citation
Alvarez A, Singh PM, Sinha AC. Postoperative analgesia in morbid obesity. Obes Surg. 2014 Apr;24(4):652-9. doi: 10.1007/s11695-014-1185-2.
Results Reference
result
Links:
URL
http://bariatrictimes.com
Description
bariatric surgery and anesthesia
Learn more about this trial
Use of MgSO4 for Pain After Bariatric Surgery
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