Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

Blindness Clinical Trial

Official title:

The Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219569
• Other study ID #: 0120070222
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: April 23, 2015
• Start date: August 2007
• Est. completion date: January 2010

Study information

• Verified date: August 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Blindness

Intervention

Drug:
• propofol
Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure
• Sevoflurane
sevoflurane 1.5% and 2.5% end tidal in random sequence

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the pupil response using different anesthetic techniques		pupillometry measurements will be taken in both eyes after induction of anesthesia	No
Secondary	Measure the pupil response using different anesthetic techniques		When steady maintenance of anesthesia drug is obtained measure pupillometry response at 10 min	No
Secondary	Measure the pupil response using different anesthetic techniques		When steady maintenance of anesthesia drug is obtaines measure pupillometry response at 20 minutes	No
Secondary	Measure the pupil response using different anesthetic technique		When steady maintenance of anesthesia drug is obtained measure pu[illometry response at 30 minutes.	No