Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

NCT ID: NCT01219569

Last Updated: 2015-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-01-31

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.

Conditions

Blindness

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

2. 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.

Sevoflurane

Intervention Type: DRUG

sevoflurane 1.5% and 2.5% end tidal in random sequence

1.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

propofol

Intervention Type: DRUG

Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure

Interventions

propofol

Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure

Intervention Type: DRUG

Sevoflurane

sevoflurane 1.5% and 2.5% end tidal in random sequence

Intervention Type: DRUG

Other Intervention Names

deprivan; Sevoflurane at 1.5 and 2.5% end tidal

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Anesthesia

Geordie Grant, MD Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geordie P. Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

University Hospital

Newark, New Jersey, United States

Countries

United States

Other Identifiers

0120070222

Identifier Type: -

Identifier Source: org_study_id