Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry

NCT ID: NCT00695890

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-09-30

Brief Summary

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Null hypothesis (HO): There will be no difference in pupillometry readings when using any of the maintenance anesthetic techniques within subjects.

Alternate hypothesis (HA): Pupillometry readings will be affected by a change in the anesthetic technique

Detailed Description

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Postoperative visual loss resulting from a surgical procedure not performed on the eye is a devastating outcome for the patient and poorly understood by the medical community. It is potentially a preventable complication. Diminished blood supply to the optic nerve, affecting both the anterior or posterior portions of the optic nerve, is the most common cause of postoperative visual loss. Other, less common causes include occlusion of the retinal artery and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual loss increases in patients undergoing cardiopulmonary bypass and prone spine surgery. Although the etiology of post-operative visual loss is unknown, it is thought to be multifactorial, and several potential risk factors have been identified, including degree of low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood loss, prolonged duration of surgical time and increased pressure in the eye associated with positioning. To date studies have focused on the mechanism associated with the visual loss. We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

Conditions

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Measurement of Pupil Diameter

Keywords

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Pupillometry Sevoflorane Propofol

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 18 and 70 years of age who are mentally capable of providing an informed consent and who are medically classified as ASA 1 or 2.
* Planned elective orthopedic extremity surgery in the supine position with the head in the neutral position.

Exclusion Criteria

* Failure to provide an informed consent
* Known history of eye disease which cannot be corrected with lenses
* Surgery lasting less than 45 minutes
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geordie Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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UMDNJ

Newark, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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012007070222

Identifier Type: -

Identifier Source: org_study_id