NCT01241175

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

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
Last Updated

November 16, 2010

Status Verified

March 1, 2009

First QC Date

November 15, 2010

Last Update Submit

November 15, 2010

Conditions

Increased Intra Ocular Pressure (IOP)

Keywords

IOPophthalmic anesthesiamagnesium sulfate

Outcome Measures

Primary Outcomes (1)

  • Intra ocular pressure

Secondary Outcomes (1)

  • blood pressure,heart rate

Study Arms (2)

magnesium sulfate

EXPERIMENTAL
Drug: Magnesium Sulfate

normal saline

PLACEBO COMPARATOR
Drug: normal saline

Interventions

Magnesium SulfateDRUG
magnesium sulfate
normal salineDRUG
normal saline

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Interventions

Magnesium SulfateSaline Solution

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Hilda Mahmoudi, M.D

    Shiraz University of Medical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Last Updated

November 16, 2010

Record last verified: 2009-03

Locations

IR(1)