Effect of Magnesium Sulphate on Neostigmine | NCT03020706

Studies
Effect of Magnesium Sulphate on Neostigmine

NCT03020706

Sponsor

Gachon University Gil Medical Center

Status

Unknown status

Last Update Posted

Jan 13, 2017Estimated

Enrollment

166Estimated

Phase

Not Applicable

Conditions

Neuromuscular Blockade

Interventions

Magnesium Sulfate, Injectable

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Jan 2017Actual

Completion Date

Dec 2017Estimated

First Submitted Date

Jan 8, 2017

First Submission Date that Met QC Criteria

Jan 11, 2017

First Posted Date

Jan 13, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 13, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Park Hee-Yeon, Associate professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Name	Class
Seoul National University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of magnesium sulphate on neostigmine-induced reversal of neuromuscular block by rocuronium

Detailed Description

Comparison of reversa time by neostigmine in magnesium group and control group

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

166Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnesium	Experimental	magnesium sulfate, injectable intravenous administration (50mg/kg diluted in 100ml normal saline) during general anesthesia	Drug: Magnesium Sulfate, Injectable
Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate, Injectable	Drug	magnesium sulphate intravenous administration during general anesthesia	Magnesium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reversal time	reversal time: from neostigmine injection to TOF ratio 0.9	through study completion, an average of 90 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA status 1 or 2
patients undergoing surgery for more than 60 min under general anesthesia

Exclusion Criteria:

electrolyte abnormalities
medication on aminoglycoside, antiepileptic drug, magnesium
underweight or obesity (BMI <18.5 or >30)
renal insufficiency (Cr>1.4 mg/dl)
AV block
neuromuscular disease (ex: Myathenia gravis)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee-Yeon Park, MD	Contact	+82 10 3360 0790		hypark@gilhospital.com
Sang-Hwan Do, MD, Ph D	Contact			shdo@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Sang-Hwan Do, MD, Ph D	Seoul National University Bundang Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam	Kyungi-do		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate
D007267	Injections

Ancestor Terms

ID	Term
D017616	Magnesium Compounds
D007287	Inorganic Chemicals
D013431	Sulfates
D013464	Sulfuric Acids

Browse Leaves

Not provided

Browse Branches

Not provided