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

Primary Purpose

Increased Intra Ocular Pressure (IOP)

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Magnesium Sulfate
normal saline
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Increased Intra Ocular Pressure (IOP) focused on measuring IOP, ophthalmic anesthesia, magnesium sulfate

Eligibility Criteria

18 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

magnesium sulfate

normal saline

Arm Description

Outcomes

Primary Outcome Measures

Intra ocular pressure

Secondary Outcome Measures

blood pressure,heart rate

Full Information

First Posted
November 15, 2010
Last Updated
November 15, 2010
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01241175
Brief Title
The Effect of Intravenous Magnesium Sulfate on Intraocular Pressure Following Tracheal Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Increased Intra Ocular Pressure (IOP)
Keywords
IOP, ophthalmic anesthesia, magnesium sulfate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
magnesium sulfate
Arm Type
Experimental
Arm Title
normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Type
Drug
Intervention Name(s)
normal saline
Primary Outcome Measure Information:
Title
Intra ocular pressure
Secondary Outcome Measure Information:
Title
blood pressure,heart rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilda Mahmoudi, M.D
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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