NCT03206008

Brief Summary

Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2017

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

June 30, 2017

Last Update Submit

April 19, 2018

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • severity of postoperative pain

    checking the postoperative pain in score at the recovery room and outpatient surgery center

    1 hour interval

Study Arms (2)

Normal saline group

PLACEBO COMPARATOR

after loading normal saline 100cc in 10-20 minutes, continuous infusion of normal saline until the end of surgery

Drug: Normal saline

Magnesium group

ACTIVE COMPARATOR

after loading magnesium sulfate dosing 50 mg/kg (100cc) in 10-20 minutes, continuous infusion of magnesium sulfate 15 mg/kg/h until the end of surgery

Drug: Magnesium Sulfate

Interventions

Magnesium SulfateDRUG
Magnesium group
Normal salineDRUG

Placebo

Normal saline group

Eligibility Criteria

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

You may qualify if:

  • aged between 18-65 year-old-patient (ASA I-II) who are planned to undergoing day surgery

You may not qualify if:

  • ASA class ≥ III
  • suspected imbalance of electrolyte
  • myocardial damage or conduction delay
  • myasthenia gravis or other neuromuscular disease
  • impaired renal function
  • already using any type of analgesia
  • denial of participating in the study or not giving the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital, department of Anesthesia and pain

Seongnam, Gyenggo-do, 13620, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • SangHwan Do

    Seoul National University Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 2, 2017

Study Start

November 18, 2016

Primary Completion

November 24, 2017

Study Completion

November 24, 2017

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)