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
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 28, 2017
CompletedFirst Posted
Study publicly available on registry
November 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2017
CompletedMay 22, 2018
May 1, 2018
12 months
September 28, 2017
May 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 day
Study Arms (2)
Group MgSO4
EXPERIMENTALThe 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)
Group Control
NO INTERVENTIONthe control group (group C, n \_ 40) received the same amount of IV saline
Interventions
The magnesium group (group Mg, n \_ 40) received an additional infusion of MgSO4
Eligibility Criteria
You may qualify if:
- to 65 year old individuals who underwent laparoscopic sleeve gastrectomy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 24431032RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
nurcan kizilcik, MD
yeditepe universityiversity
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof. Dr.
Study Record Dates
First Submitted
September 28, 2017
First Posted
November 28, 2017
Study Start
January 1, 2017
Primary Completion
December 15, 2017
Study Completion
December 15, 2017
Last Updated
May 22, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share