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
Scientific
600 N. Wolfe Street
Wilmer 120
Baltimore
21287
United States of America
| Phone | +1 410 614 5561 |
|---|---|
| ncongdon@jhmi.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sevoflourane and ketamine |
| Primary outcome measure | 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 study start date | 01/01/2005 |
| Completion date | 30/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Patients undergoing general anesthesia. |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 30/12/2005 |
Locations
Countries of recruitment
- United States of America
Study participating centre
600 N. Wolfe Street
Baltimore
21287
United States of America
21287
United States of America
Sponsor information
Wilmer Eye Institute (USA)
Research organisation
Research organisation
600 N. Wolfe Street
Baltimore
21287
United States of America
| Phone | +1 410 614 5561 |
|---|---|
| ncongdon@jhmi.edu | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
