Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry
This study has been completed.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
First received: June 9, 2008
Last updated: December 17, 2014
Last verified: December 2014
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
Measurement of Pupil Diameter
||Observational Model: Cohort
Time Perspective: Prospective
||Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry.
Primary Outcome Measures:
- We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2009 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- Failure to provide an informed consent
- Known history of eye disease which cannot be corrected with lenses
- Surgery lasting less than 45 minutes
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00695890
|Newark, New Jersey, United States, 07101 |
University of Medicine and Dentistry of New Jersey
||Geordie Grant, MD
||Rutgers, The State University of New Jersey
||University of Medicine and Dentistry of New Jersey
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 9, 2008
||December 17, 2014
||United States: Institutional Review Board
Keywords provided by Rutgers, The State University of New Jersey:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 30, 2016
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