NCT01273831

Brief Summary

The purpose of this study is to determine which drug makes lower intraocular pressure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
Last Updated

January 11, 2011

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

January 10, 2011

Last Update Submit

January 10, 2011

Conditions

Intraocular Pressure

Keywords

intraocular pressure, anesthesia,cisatracurium,atracurium.

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    determining intraocular pressure in atracurium and cisatracurium groups

    at 2 minutes after intubation

Secondary Outcomes (1)

  • systolic blood pressure

    at 2 minutes after intubation

Study Arms (2)

atracurium

OTHER

Patients who underwent general anesthesia received atracurium

Drug: atracurium

cisatracurium

OTHER

Patients who underwent general anesthesia received cisatracurium

Drug: cisatracurium

Interventions

atracuriumDRUG

atracurium, Drop,0.5 mg/kg, one time, one day

atracurium
cisatracuriumDRUG

cisatracurium, drop,0.15mg/kg,one time, one day

cisatracurium

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration.

You may not qualify if:

  • difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Interventions

Atracuriumcisatracurium

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mitra Jabalameri, A.Professor

    Associate Professor,Anesthesiology department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 11, 2011

Record last verified: 2009-07

Locations

IR(1)