The Effect of Intraoperative Magnesium Sulfate Infusion o... | NCT03206008

Studies
The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery

NCT03206008

Sponsor

Seoul National University Bundang Hospital

Status

Terminated

Last Update Posted

Apr 20, 2018Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Magnesium Sulfate
Normal saline

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

hard to get an informed concent because of small number of indiaiton of surgery

Expanded Access Info

Start Date

Nov 18, 2016Actual

Primary Completion Date

Nov 24, 2017Actual

Completion Date

Nov 24, 2017Actual

First Submitted Date

Jun 30, 2017

First Submission Date that Met QC Criteria

Jun 30, 2017

First Posted Date

Jul 2, 2017Actual

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

Apr 19, 2018

Last Update Posted Date

Apr 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LEE YEA JI, clinical professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug		Magnesium group
Normal saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
severity of postoperative pain	checking the postoperative pain in score at the recovery room and outpatient surgery center	1 hour interval

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SangHwan Do	Seoul National University Bundang Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital, department of Anesthesia and pain		Seongnam	Gyenggo-do	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008278	Magnesium Sulfate
D000077330	Saline Solution

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided