Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

Completed

• Conditions: Blindness
• Interventions: Drug: Sevoflurane; Drug: propofol

• Registration Number: NCT01219569
• Lead Sponsor: Rutgers, The State University of New Jersey

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-04-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Status Verified: 2013-08
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• planned orthopedic surgery on the lower extremities and positioned on the back

Exclusion Criteria

• recent bout of conjunctivitis or pink eye
• condition which inhibits the normal pupillary function of my eye

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2. Sevoflurane	Sevoflurane	Subjects will receive sevoflurane at 1.5% and 2.5% end tidal after steady state maintenance has been achieved and have pupillometry readings taken and every 10 minutes for 30 minute at each drug dose.
1.Propofol	propofol	1.Subjects will receive propofol infusion and have pupillometry readings taken in both eyes after induction, after steady state maintenance has been achieved and at 30 minutes

Primary Outcome Measures

Name	Time	Method
Measure the pupil response using different anesthetic techniques	pupillometry measurements will be taken in both eyes after induction of anesthesia

Secondary Outcome Measures

Name	Time	Method
Measure the pupil response using different anesthetic techniques	When steady maintenance of anesthesia drug is obtaines measure pupillometry response at 20 minutes
Measure the pupil response using different anesthetic technique	When steady maintenance of anesthesia drug is obtained measure pu[illometry response at 30 minutes.

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Newark, New Jersey, United States