Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry

Measurement of Pupil Diameter Clinical Trial

Official title:

Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695890
• Other study ID #: 012007070222
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: December 17, 2014
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: December 2014
• 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

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Measurement of Pupil Diameter

Locations

Country	Name	City	State
United States	UMDNJ	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.		18 months	No