Vision; Disorder, LossNCT03644641
The Influence of Prone Position for Spinal Surgery on Visual Acuity
A study testing Desflurane Group and Propofol Group in people with Vision; Disorder, Loss, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
This study investigated the effect of desflurane and propofol anesthesia on visual acuity in patients in prone position for spinal surgery. Many trials have investigated the effects of different anesthetic agents on intraocular pressure, propofol may reduce intraocular pressure more than other intravenous anesthetics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vision; Disorder, Loss
- What is being tested?
- Desflurane Group and Propofol Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 28 Nov 2025to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow Coma scale 15
- American Society of Anesthesiologists (ASA) Physical Status Classification System I-III
- spinal surgery in duration less than 3 hours
- sinus rhythm
Who cannot join
- postoperative artificial ventilation
- serious neurological disease
- lung disease with hypercapnia
- propofol allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site
University Hospital Hradec Kralove
Hradec Králové, 50005
Suchy Tomas, MD, 00420495833218, suchy@fnhk.cz
Dostal Pavel, MD, PhD, 00420495832828, pavel.dostal@fnhk.cz
About this study
Official title: The Influence of Prone Position for Spinal Surgery on Visual Acuity, a Comparison of Volatile Anesthesia With Desflurane to Total Intravenous Anesthesia With Propofol
This study investigated the effect of desflurane and propofol anesthesia on visual acuity in patients in prone position for spinal surgery. Many trials have investigated the effects of different anesthetic agents on intraocular pressure, propofol may reduce intraocular pressure more than other intravenous anesthetics.
Read the detailed description
Perioperative increase in intraocular pressure can be caused by prone positioning. In addition to surgical factors, patients with glaucoma, uncontrolled hypertension, arthrosclerosis, and morbid obesity are at risk for potentially damaging optic nerve and loss of optic nerve function. Some studies found that intraocular pressure values were significantly lower in patients undergoing propofol total intravenous anesthesia than in patients undergoing desflurane anesthesia during intraoperative positional changes. Pronounced vasodilatation caused by desflurane might produced hyperaemia with higher intraocular pressure. Hemodynamic response to prone position measured by near-infrared spectroscopy (NIRS) on the prefrontal cortex could determine changes caused by prone position.
- Conditions
- Vision; Disorder, Loss
- Being tested
- Desflurane Group, Propofol Group
- Keywords
- Desflurane, Near-infrared spectroscopy, Propofol, Spinal surgery, Prone position, Visual acuity, Visual loss
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane GroupProcedure or surgery
General anesthesia will be held using desflurane in end- tidal concentration according to target value of entropy levels (between 40 and 60).
Propofol GroupProcedure or surgery
General anesthesia will be held using Schnider effect model for propofol (target control anesthesia). Titration will be done according to target value of entropy levels (between 40 and 60).
| Study group | Role | What they receive |
|---|---|---|
| Desflurane Group | Experimental | Induction and anesthesia will be held by using desflurane Receives: Procedure: Desflurane Group |
| Propofol Group | Experimental | Induction and anesthesia will be held by using target-control anesthesia with propofol Receives: Procedure: Propofol Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual injury
worsening of test for visual acuity (Rodenstock)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start28 Nov 2025 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision; Disorder, LossStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Pavel Dostal, MD, Ph.D., Study director, Hradec Kralove, Czechia 50005
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644641
- Sponsor's protocol ID
- UHospital Hradec Kral
- Status last verified
- May 2024
- First submitted
- 21 Aug 2018
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Prone Position for Spinal Surgery on Visual Acuity, a Comparison of Volatile Anesthesia With Desflurane to Total Intravenous Anesthesia With Propofol
- ClinicalTrials.gov ID
- NCT03644641
- Acronym / sponsor ID
- UHospital Hradec Kral
- Conditions
- Vision; Disorder, Loss
- Keywords
- Desflurane, Near-infrared spectroscopy, Propofol, Spinal surgery, Prone position, Visual acuity, Visual loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 28 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 23 Aug 2018 (actual)
- 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 study investigated the effect of desflurane and propofol anesthesia on visual acuity in patients in prone position for spinal surgery. Many trials have investigated the effects of different anesthetic agents on intraocular pressure, propofol may reduce intraocular pressure more than other intravenous anesthetics.
Detailed description
Perioperative increase in intraocular pressure can be caused by prone positioning. In addition to surgical factors, patients with glaucoma, uncontrolled hypertension, arthrosclerosis, and morbid obesity are at risk for potentially damaging optic nerve and loss of optic nerve function. Some studies found that intraocular pressure values were significantly lower in patients undergoing propofol total intravenous anesthesia than in patients undergoing desflurane anesthesia during intraoperative positional changes. Pronounced vasodilatation caused by desflurane might produced hyperaemia with higher intraocular pressure. Hemodynamic response to prone position measured by near-infrared spectroscopy (NIRS) on the prefrontal cortex could determine changes caused by prone position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane Group | Experimental | Procedure: Desflurane GroupInduction and anesthesia will be held by using desflurane |
| Propofol Group | Experimental | Procedure: Propofol GroupInduction and anesthesia will be held by using target-control anesthesia with propofol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Glasgow Coma scale 15
- American Society of Anesthesiologists (ASA) Physical Status Classification System I-III
- spinal surgery in duration less than 3 hours
- sinus rhythm
Key exclusion criteria (4 listed)
- postoperative artificial ventilation
- serious neurological disease
- lung disease with hypercapnia
- propofol allergy
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 |
|---|---|---|
| Desflurane GroupGeneral anesthesia will be held using desflurane in end- tidal concentration according to target value of entropy levels (between 40 and 60). | Procedure or surgery | Desflurane Group |
| Propofol GroupGeneral anesthesia will be held using Schnider effect model for propofol (target control anesthesia). Titration will be done according to target value of entropy levels (between 40 and 60). | Procedure or surgery | Propofol Group |
Primary outcome
Visual injury
Time frame: 48 hours
worsening of test for visual acuity (Rodenstock)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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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.
Pavel Dostal, MD, Ph.D. study director
Hradec Kralove, Czechia 50005
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane Group and Propofol Group in people with Vision; Disorder, Loss, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 May 2024. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vlasta Dostalova, MD, Ph.D. (+420777883571, vlasta.dostalova@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual injury (time frame: 48 hours). 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 10 May 2024.