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Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, June 2008
Sponsored by: University of Medicine and Dentistry New Jersey
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00695890
  Purpose

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


Condition
Pupillometry

MedlinePlus related topics: Anesthesia
Drug Information available for: Propofol Sevoflurane
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry.

Further study details as provided by University of Medicine and Dentistry New Jersey:

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 8
Study Start Date: September 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy volunteers

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy volunteers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695890

Contacts
Contact: Geordie Grant, MD 973-972-5254 grantgp@umdnj.edu

Locations
United States, New Jersey
UMDNJ Recruiting
Newark, New Jersey, United States, 07101
Contact: Geordie Grant, MD     973-972-5254     grantgp@umdnj.edu    
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Geordie Grant, MD University of Medicine and Dentistry New Jersey
  More Information

Responsible Party: UMDNJ ( Geordie Grant, MD_ )
Study ID Numbers: 012007070222
Study First Received: June 9, 2008
Last Updated: June 11, 2008
ClinicalTrials.gov Identifier: NCT00695890  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Pupillometry
Sevoflorane
Propofol

Study placed in the following topic categories:
Propofol
Sevoflurane

Additional relevant MeSH terms:
Anesthetics, Intravenous
Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Hematologic Agents
Hypnotics and Sedatives
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Platelet Aggregation Inhibitors
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009