NCT03355807

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

12 months

First QC Date

September 28, 2017

Last Update Submit

May 21, 2018

Conditions

Keywords

sleeve gastrectomymagnesium sulfatepostoperative painbariatric surgery

Outcome Measures

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.

    1 day

Study Arms (2)

Group MgSO4

EXPERIMENTAL

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

Group Control

NO INTERVENTION

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

Group MgSO4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • nurcan kizilcik, MD

    yeditepe universityiversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The patients undergoing sleeve gastrectomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

September 28, 2017

First Posted

November 28, 2017

Study Start

January 1, 2017

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share