Use of MgSO4 for Pain After Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT03355807|
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : May 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Therapeutic Opioid Induced Constipation (Disorder)||Drug: Magnesium||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The patients undergoing sleeve gastrectomy.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes 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|
|Official Title:||Use of MgSO4 Reduced Opioid Consumption for Pain After Sleeve Gastrectomy Operations: A Prospective Randomized Clinical Trial|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||December 15, 2017|
|Actual Study Completion Date :||December 15, 2017|
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
- 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.
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): NCT03355807
|Principal Investigator:||nurcan kizilcik, MD||yeditepe universityiversity|