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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03355807
Other study ID # obesity (magnesium)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date December 15, 2017

Study information

Verified date May 2018
Source Yeditepe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 15, 2017
Est. primary completion date December 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Constipation
  • Therapeutic Opioid Induced Constipation (Disorder)

Intervention

Drug:
Magnesium
The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University Hospital

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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