Contact information
Type
Scientific
Primary contact
Dr Nathan Congdon
ORCID ID
Contact details
600 N. Wolfe Street
Wilmer 120
Baltimore
21287
United States of America
+1 410 614 5561
ncongdon@jhmi.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Glaucoma 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Glaucoma
Intervention
Intraocular 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 type
Drug
Phase
Not Specified
Drug names
Sevoflourane and ketamine
Primary outcome measures
Change 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 measures
Effect of pulse, blood pressure, oxygenation, baseline IOP, baseline eye disease on intraocular pressure.
Overall trial start date
01/01/2005
Overall trial end date
30/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing general anesthesia.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients unwilling/unable to give informed consent
2. Patients with irregular corneas or other ocular abnormalities not allowing for an adequate IOP measurement
Recruitment start date
01/01/2005
Recruitment end date
30/12/2005
Locations
Countries of recruitment
United States of America
Trial participating centre
600 N. Wolfe Street
Baltimore
21287
United States of America
Sponsor information
Organisation
Wilmer Eye Institute (USA)
Sponsor details
600 N. Wolfe Street
Baltimore
21287
United States of America
+1 410 614 5561
ncongdon@jhmi.edu
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Wilmer Eye Institute (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary