Comparison of the effects of sevoflourane and ketamine on intraocular pressure (IOP) in healthy patients and patients with glaucoma

ISRCTN ISRCTN22914223
DOI https://doi.org/10.1186/ISRCTN22914223
Secondary identifying numbers N/A
Submission date
18/10/2005
Registration date
16/11/2005
Last edited
21/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nathan Congdon
Scientific

600 N. Wolfe Street
Wilmer 120
Baltimore
21287
United States of America

Phone +1 410 614 5561
Email ncongdon@jhmi.edu

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesGlaucoma is a slowly progressive optic neuropathy which may rarely be seen in children, and is a leading cause of visual loss in adults. The effects of ketamine and sevoflourane, two commonly used anesthetic agents, on intraocular pressure, are not well known. Serial measurements of IOP in patients randomised to one of the two anesthetic agents will be evaluated. Eyes may be glaucomatous or healthy. Confounding variables, including pulse, blood pressure, oxygenation, will be recorded and evaluated.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedGlaucoma
InterventionIntraocular pressure measurements will be recorded in patients with glaucoma and in healthy patients.

Both sevoflourane and ketamine are commonly used anaesthetic agents. Patients will be randomised to one of the two groups unless the anaesthesiologist or patient prefer one of the agents.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sevoflourane and ketamine
Primary outcome measureChange in intraocular pressure after administration of anesthetic agent:
1. How greatly does the IOP change?
2. What percentage of patients in each group have a statistically significant change?
Secondary outcome measuresEffect of pulse, blood pressure, oxygenation, baseline IOP, baseline eye disease on intraocular pressure.
Overall study start date01/01/2005
Completion date30/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Key inclusion criteriaPatients undergoing general anesthesia.
Key exclusion criteria1. Patients unwilling/unable to give informed consent
2. Patients with irregular corneas or other ocular abnormalities not allowing for an adequate IOP measurement
Date of first enrolment01/01/2005
Date of final enrolment30/12/2005

Locations

Countries of recruitment

  • United States of America

Study participating centre

600 N. Wolfe Street
Baltimore
21287
United States of America

Sponsor information

Wilmer Eye Institute (USA)
Research organisation

600 N. Wolfe Street
Baltimore
21287
United States of America

Phone +1 410 614 5561
Email ncongdon@jhmi.edu
ROR logo "ROR" https://ror.org/05cb1k848

Funders

Funder type

Research organisation

Wilmer Eye Institute (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan