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Trial record 23 of 658 for:    Sevoflurane

Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry

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ClinicalTrials.gov Identifier: NCT01219569
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey

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

Condition or disease Intervention/treatment
Blindness Drug: propofol Drug: Sevoflurane

Detailed Description:
The degree of a relative afferent pupillary defect (RAPD) has been correlated with the severity of an eye injury and has been shown to have prognostic significance as an indicator of retinal ischemia. Therefore light flashed evoked pupillometry (LFEP) may serve as a useful indicator of visual function. LFEP's are not known to be sensitive to anesthetics. We will measure LFEP's using different anesthetic techniques to see if there are measurable differences in the latency, amplitude and constriction velocity of the pupillary reflex. Prior to induction of anesthesia, pupillometer readings will be taken in the supine position in both eyes. The patient will be anesthetised using a standard induction technique. For maintenance of anesthesia a remifentanil infusion will be administered and supplemented by either propofol infusion (at 120 and 160 mcg/kg/min)or sevoflurane (at 1.5 and 2.5% end-tidal in random sequence. The patients will receive muscle relaxants as needed. Pupillometry readings will be taken in both eyes after induction, after steady maintenance has been achieved and every 10 minutes for 30 minutes at each drug dose.

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Study Type : Observational
Actual Enrollment : 35 participants
Time Perspective: Prospective
Official Title: The Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
Study Start Date : August 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010


Group/Cohort Intervention/treatment
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
sevoflurane 1.5% and 2.5% end tidal in random sequence
Other Name: Sevoflurane at 1.5 and 2.5% end tidal

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




Primary Outcome Measures :
  1. Measure the pupil response using different anesthetic techniques [ Time Frame: pupillometry measurements will be taken in both eyes after induction of anesthesia ]

Secondary Outcome Measures :
  1. Measure the pupil response using different anesthetic techniques [ Time Frame: When steady maintenance of anesthesia drug is obtained measure pupillometry response at 10 min ]
  2. Measure the pupil response using different anesthetic techniques [ Time Frame: When steady maintenance of anesthesia drug is obtaines measure pupillometry response at 20 minutes ]
  3. Measure the pupil response using different anesthetic technique [ Time Frame: When steady maintenance of anesthesia drug is obtained measure pu[illometry response at 30 minutes. ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects undergoing orthopedic surgery in the supine position
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT01219569


Locations
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United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Geordie P. Grant, MD Rutgers, The State University of New Jersey

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Responsible Party: Anesthesia, Geordie Grant, MD Associate Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01219569     History of Changes
Other Study ID Numbers: 0120070222
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: August 2013

Keywords provided by Anesthesia, Rutgers, The State University of New Jersey:
blindness
ischemic optic neuropathy

Additional relevant MeSH terms:
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Sevoflurane
Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation