Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Rutgers, The State University of New Jersey.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00695890
First received: June 9, 2008
Last updated: June 11, 2008
Last verified: June 2008
  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

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:

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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 of New Jersey
Investigators
Principal Investigator: Geordie Grant, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

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

Keywords provided by Rutgers, The State University of New Jersey:
Pupillometry
Sevoflorane
Propofol

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

ClinicalTrials.gov processed this record on July 24, 2014