Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT01219569
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2009-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
The Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.
Detailed Description:
The degree of a relative afferent pupillary defect (RAPD) has been correlated with the severity of an eye injury and has been shown to have prognostic significance as an indicator of retinal ischemia. Therefore light flashed evoked pupillometry (LFEP) may serve as a useful indicator of visual function. LFEP's are not known to be sensitive to anesthetics. We will measure LFEP's using different anesthetic techniques to see if there are measurable differences in the latency, amplitude and constriction velocity of the pupillary reflex. Prior to induction of anesthesia, pupillometer readings will be taken in the supine position in both eyes. The patient will be anesthetised using a standard induction technique. For maintenance of anesthesia a remifentanil infusion will be administered and supplemented by either propofol infusion (at 120 and 160 mcg/kg/min)or sevoflurane (at 1.5 and 2.5% end-tidal in random sequence. The patients will receive muscle relaxants as needed. Pupillometry readings will be taken in both eyes after induction, after steady maintenance has been achieved and every 10 minutes for 30 minutes at each drug dose.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: