Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

NCT01219569 | Completed

• 1 other identifier: 0120070222
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

Conditions

Blindness

Keywords

blindness; ischemic optic neuropathy

Outcome Measures

Primary Outcomes (1)

• Measure the pupil response using different anesthetic techniques

  pupillometry measurements will be taken in both eyes after induction of anesthesia

Secondary Outcomes (3)

• Measure the pupil response using different anesthetic techniques

  When steady maintenance of anesthesia drug is obtained measure pupillometry response at 10 min

• Measure the pupil response using different anesthetic techniques

  When steady maintenance of anesthesia drug is obtaines measure pupillometry response at 20 minutes

• Measure the pupil response using different anesthetic technique

  When steady maintenance of anesthesia drug is obtained measure pu[illometry response at 30 minutes.

Study Arms (2)

2. Sevoflurane

Subjects will receive sevoflurane at 1.5% and 2.5% end tidal after steady state maintenance has been achieved and have pupillometry readings taken and every 10 minutes for 30 minute at each drug dose.

Drug: Sevoflurane

1.Propofol

1.Subjects will receive propofol infusion and have pupillometry readings taken in both eyes after induction, after steady state maintenance has been achieved and at 30 minutes

Drug: propofol

Interventions

propofol DRUG

Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure

Also known as: deprivan

1.Propofol

Sevoflurane DRUG

sevoflurane 1.5% and 2.5% end tidal in random sequence

Also known as: Sevoflurane at 1.5 and 2.5% end tidal

2. Sevoflurane

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects undergoing orthopedic surgery in the supine position

You may qualify if:

• planned orthopedic surgery on the lower extremities and positioned on the back

You may not qualify if:

• recent bout of conjunctivitis or pink eye
• condition which inhibits the normal pupillary function of my eye

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Blindness; Optic Neuropathy, Ischemic

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Optic Nerve Diseases; Cranial Nerve Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Geordie P. Grant, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Geordie Grant, MD Associate Professor

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: October 13, 2010
• Study Start: August 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 24, 2015

Record last verified: 2013-08

Locations

US (1)