NCT00695890

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

June 9, 2008

Last Update Submit

December 17, 2014

Conditions

Measurement of Pupil Diameter

Keywords

PupillometrySevofloranePropofol

Outcome Measures

Primary Outcomes (1)

  • We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

    18 months

Study Arms (1)

1

Healthy volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • Failure to provide an informed consent
  • Known history of eye disease which cannot be corrected with lenses
  • Surgery lasting less than 45 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ

Newark, New Jersey, 07101, United States

Location

Study Officials

  • Geordie Grant, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 12, 2008

Study Start

September 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

December 19, 2014

Record last verified: 2014-12

Locations

US(1)