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NCT01273831 Clinical Trial

Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia

Intraocular Pressure Clinical Trial

Official title:
Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01273831
Other study ID # ASD-1213-10
Secondary ID
Status Completed
Phase Phase 2
First received January 10, 2011
Last updated January 10, 2011
Start date July 2009
Est. completion date December 2009

Study information
Verified date July 2009
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Description:

Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• atracurium
atracurium, Drop,0.5 mg/kg, one time, one day
• cisatracurium
cisatracurium, drop,0.15mg/kg,one time, one day

Locations
Country Name City State
Iran, Islamic Republic of Al-zahra university hospital Isfahan

Sponsors (1)
Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary intraocular pressure determining intraocular pressure in atracurium and cisatracurium groups at 2 minutes after intubation Yes
Secondary systolic blood pressure identification of systolic blood pressure in atracurium and cisatracurium groups at 2 minutes after intubation Yes
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