The Effect of Intravenous Magnesium Sulfate on Intraocula... | NCT01241175

Studies
The Effect of Intravenous Magnesium Sulfate on Intraocular Pressure Following Tracheal Intubation

NCT01241175

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Nov 16, 2010Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Increased Intra Ocular Pressure (IOP)

Interventions

Magnesium Sulfate
normal saline

Countries

Iran

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

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 15, 2010

First Posted Date

Nov 16, 2010Estimated

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

Nov 15, 2010

Last Update Posted Date

Nov 16, 2010Estimated

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 aim of this study is to assess the effect of preoperatively administered intra venous magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal intubation in adult patients scheduled for elective non ocular surgery

Detailed Description

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
magnesium sulfate	Experimental		Drug: Magnesium Sulfate
normal saline	Placebo Comparator		Drug: normal saline

Name	Type	Description	Arm Group Labels	Other Names
Magnesium Sulfate	Drug		magnesium sulfate
normal saline

Measure	Description	Time Frame
Intra ocular pressure

Measure	Description	Time Frame
blood pressure,heart rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 38 years old
ASA I
scheduled for elective ENT ambulatory surgeries under general anesthesia

Exclusion Criteria:

specific major hepatic, renal and cardio-vascular disease
known to have allergic reaction to magnesium sulphate or other drugs , -hypermagnesemia
hypocalcemia
anuria
heart block
pregnancy
any degree of renal insufficiency
digitalised patients
positive history of glaucoma or intra ocular hypertension
refused to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hilda Mahmoudi, M.D	Shiraz University of Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiraz University of Medical Sciences		Shiraz	Fars		Iran

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