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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01273831
First received: January 10, 2011
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Intraocular Pressure
 Drug: atracurium
Drug: cisatracurium
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: at 2 minutes after intubation ] [ Designated as safety issue: Yes ]
    determining intraocular pressure in atracurium and cisatracurium groups


Secondary Outcome Measures:
  • systolic blood pressure [ Time Frame: at 2 minutes after intubation ] [ Designated as safety issue: Yes ]
    identification of systolic blood pressure in atracurium and cisatracurium groups


Enrollment: 90
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
atracurium
Patients who underwent general anesthesia received atracurium
 Drug: atracurium
atracurium, Drop,0.5 mg/kg, one time, one day
cisatracurium
Patients who underwent general anesthesia received cisatracurium
 Drug: cisatracurium
cisatracurium, drop,0.15mg/kg,one time, one day

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273831

Locations
Iran, Islamic Republic of
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
  More Information

Additional Information:
(Isfahan university of medical sciences)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01273831     History of Changes
Other Study ID Numbers: ASD-1213-10
Study First Received: January 10, 2011
Last Updated: January 10, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
intraocular pressure, anesthesia,cisatracurium,atracurium.

Additional relevant MeSH terms:
Anesthetics
Atracurium
Cisatracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Nicotinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013