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Use of MgSO4 for Pain After Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355807
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
nurcan kizilcik, Yeditepe University Hospital

Brief Summary:
The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation

Condition or disease Intervention/treatment Phase
Therapeutic Opioid Induced Constipation (Disorder) Drug: Magnesium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
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
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


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)
Drug: Magnesium
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Yeditepe University Hospital
Investigators
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Principal Investigator: nurcan kizilcik, MD yeditepe universityiversity
Additional Information:
Publications of Results:
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Responsible Party: nurcan kizilcik, Assist. Prof. Dr., Yeditepe University Hospital
ClinicalTrials.gov Identifier: NCT03355807    
Other Study ID Numbers: obesity (magnesium)
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by nurcan kizilcik, Yeditepe University Hospital:
sleeve gastrectomy
magnesium sulfate
postoperative pain
bariatric surgery
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms