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Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00695890
First Posted: June 12, 2008
Last Update Posted: December 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
  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
Measurement of Pupil Diameter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry.

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of 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 ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: September 2009
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695890


Locations
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Geordie Grant, MD Rutgers, The State University of New Jersey
  More Information

Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00695890     History of Changes
Other Study ID Numbers: 012007070222
First Submitted: June 9, 2008
First Posted: June 12, 2008
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
Pupillometry
Sevoflorane
Propofol

Additional relevant MeSH terms:
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation