Use of MgSO4 for Pain After Bariatric Surgery

NCT ID: NCT03355807

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Therapeutic Opioid Induced Constipation (Disorder)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients undergoing sleeve gastrectomy.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Magnesium

Intervention Type DRUG

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

Group Control

the control group (group C, n \_ 40) received the same amount of IV saline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Magnesium

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yeditepe University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

nurcan kizilcik

Assist. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

nurcan kizilcik, MD

Role: PRINCIPAL_INVESTIGATOR

yeditepe universityiversity

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 24431032 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://bariatrictimes.com

bariatric surgery and anesthesia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

obesity (magnesium)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pain and Magnesium
NCT03063931 UNKNOWN PHASE2
Pain Management Study
NCT05231460 ENROLLING_BY_INVITATION PHASE4
Multimodal and Unimodal Analgesia in Cholecystectomy
NCT05547659 COMPLETED PHASE1/PHASE2