BlindnessNCT01219569
Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
An observational study of Blindness, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Blindness
- What is being tested?
- propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects undergoing orthopedic surgery in the supine position
Who may be able to join
- planned orthopedic surgery on the lower extremities and positioned on the back
Who cannot join
- recent bout of conjunctivitis or pink eye
- condition which inhibits the normal pupillary function of my eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
This is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.
Read the 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.
- Conditions
- Blindness
- Being tested
- propofol, Sevoflurane
- Keywords
- blindness, ischemic optic neuropathy
- Medical subject headings
- Blindness, Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called deprivan
Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure
SevofluraneDrug
Also called Sevoflurane at 1.5 and 2.5% end tidal
sevoflurane 1.5% and 2.5% end tidal in random sequence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the pupil response using different anesthetic techniques
Measured: pupillometry measurements will be taken in both eyes after induction of anesthesia
Secondary outcomes (3)
Measure the pupil response using different anesthetic techniques
Measured: When steady maintenance of anesthesia drug is obtained measure pupillometry response at 10 min
Measure the pupil response using different anesthetic techniques
Measured: When steady maintenance of anesthesia drug is obtaines measure pupillometry response at 20 minutes
Measure the pupil response using different anesthetic technique
Measured: When steady maintenance of anesthesia drug is obtained measure pu[illometry response at 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlindnessStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anesthesia, Rutgers, The State University of New Jersey
- Investigators
- Geordie P. Grant, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219569
- Sponsor's protocol ID
- 0120070222
- Status last verified
- Aug 2013
- First submitted
- 1 Apr 2009
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sevoflurane and Propofol on Light Flashed Evoked Pupillometry
- ClinicalTrials.gov ID
- NCT01219569
- Acronym / sponsor ID
- 0120070222
- Conditions
- Blindness
- Keywords
- blindness, ischemic optic neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2. Sevoflurane | – | Drug: SevofluraneSubjects 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. |
| 1.Propofol | – | Drug: propofol1.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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects undergoing orthopedic surgery in the supine position
Key inclusion criteria (1 listed)
- planned orthopedic surgery on the lower extremities and positioned on the back
Key exclusion criteria (2 listed)
- recent bout of conjunctivitis or pink eye
- condition which inhibits the normal pupillary function of my eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: deprivanPropofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure | Drug | 1.Propofol |
| SevofluraneAlso: Sevoflurane at 1.5 and 2.5% end tidalsevoflurane 1.5% and 2.5% end tidal in random sequence | Drug | 2. Sevoflurane |
Primary outcome
Measure the pupil response using different anesthetic techniques
Time frame: pupillometry measurements will be taken in both eyes after induction of anesthesia
3 secondary outcomes
Measure the pupil response using different anesthetic techniques
Time frame: When steady maintenance of anesthesia drug is obtained measure pupillometry response at 10 min
Measure the pupil response using different anesthetic techniques
Time frame: When steady maintenance of anesthesia drug is obtaines measure pupillometry response at 20 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geordie P. Grant, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blindness, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the pupil response using different anesthetic techniques (time frame: pupillometry measurements will be taken in both eyes after induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.