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CompletedNCT03355807Updated May 22, 2018

Use of MgSO4 for Pain After Bariatric Surgery

An interventional study of Magnesium in Therapeutic Opioid Induced Constipation (Disorder), sponsored by Yeditepe University Hospital. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-22.

Sponsored by Yeditepe University Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2017, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Therapeutic Opioid Induced Constipation (Disorder)

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Keywords

  • sleeve gastrectomy
  • magnesium sulfate
  • postoperative pain
  • bariatric surgery
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Yeditepe University Hospital is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 to 65 year old individuals who underwent laparoscopic sleeve gastrectomy.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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

  • No intervention
    Group Control

    the 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

06

What researchers measure

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.

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 24431032 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03355807
Lead sponsor
Yeditepe University Hospital
Responsible party
nurcan kizilcik (Assist. Prof. Dr., Yeditepe University Hospital) — Principal investigator
First posted
Nov 28, 2017
Start date
Jan 1, 2017
Primary completion
Dec 15, 2017
Completion
Dec 15, 2017
Last update
May 22, 2018

Study contacts

nurcan kizilcik, MD
principal investigator · yeditepe universityiversity

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Magnesium

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