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

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01273831
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 17.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intraocular Pressure	Drug: atracurium; Drug: cisatracurium	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: atracurium Patients who underwent general anesthesia received atracurium	Drug: atracurium; atracurium, Drop,0.5 mg/kg, one time, one day
Other: cisatracurium Patients who underwent general anesthesia received cisatracurium	Drug: cisatracurium; cisatracurium, drop,0.15mg/kg,one time, one day

Outcome Measures

Primary Outcome Measures

1. intraocular pressure [at 2 minutes after intubation]

   determining intraocular pressure in atracurium and cisatracurium groups

Secondary Outcome Measures

1. systolic blood pressure [at 2 minutes after intubation]

   identification of systolic blood pressure in atracurium and cisatracurium groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-zahra university hospital	Isfahan		Iran, Islamic Republic of

Sponsors and Collaborators

• Isfahan University of Medical Sciences

Investigators

• Study Chair: Mitra Jabalameri, A.Professor, Associate Professor,Anesthesiology department

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• (Isfahan university of medical sciences)

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01273831
• Other Study ID Numbers: ASD-1213-10
• First Posted: Jan 11, 2011
• Last Update Posted: Jan 11, 2011
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: intraocular pressure, anesthesia,cisatracurium,atracurium.
• Additional relevant MeSH terms: Cisatracurium; Atracurium

Study Results

No Results Posted as of Jan 11, 2011