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Completed

NCT Number: NCT01219569

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.

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Key information

Conditions

Blindness Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Optic Nerve Diseases Optic Neuropathy, Ischemic Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vascular Diseases Vision Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Newark, New Jersey, 07101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Other names: deprivan

Sevoflurane

Drug

sevoflurane 1.5% and 2.5% end tidal in random sequence

Other names: Sevoflurane at 1.5 and 2.5% end tidal

Primary outcomes

  1. Measure the pupil response using different anesthetic techniques

    Time frame: pupillometry measurements will be taken in both eyes after induction of anesthesia

Secondary outcomes

  1. Measure the pupil response using different anesthetic techniques

    Time frame: When steady maintenance of anesthesia drug is obtained measure pupillometry response at 10 min

  2. Measure the pupil response using different anesthetic techniques

    Time frame: When steady maintenance of anesthesia drug is obtaines measure pupillometry response at 20 minutes

  3. Measure the pupil response using different anesthetic technique

    Time frame: When steady maintenance of anesthesia drug is obtained measure pu[illometry response at 30 minutes.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

The Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 13, 2010
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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