Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

The Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

This is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

Study Overview

• Status: Completed
• Conditions: Blindness
• Intervention / Treatment: Drug: Sevoflurane; Drug: propofol

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07101
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects undergoing orthopedic surgery in the supine position

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Sevoflurane; sevoflurane 1.5% and 2.5% end tidal in random sequence; Other Names: Sevoflurane at 1.5 and 2.5% end tidal
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	Drug: propofol; Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure; Other Names: deprivan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure the pupil response using different anesthetic techniques	When steady maintenance of anesthesia drug is obtained measure pupillometry response at 10 min
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.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Geordie P. Grant, MD, Rutgers, the State University of New Jersey

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: April 1, 2009
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (ESTIMATE): October 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 23, 2015
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: blindness; ischemic optic neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: 0120070222