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Not yet recruitingNCT03644641Updated May 10, 2024

The Influence of Prone Position for Spinal Surgery on Visual Acuity

An interventional study of Desflurane Group and Propofol Group in Vision; Disorder, Loss, sponsored by University Hospital Hradec Kralove. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by University Hospital Hradec Kralove · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Vision; Disorder, Loss

Keywords

  • Desflurane
  • Near-infrared spectroscopy
  • Propofol
  • Spinal surgery
  • Prone position
  • Visual acuity
  • Visual loss
03

In context

Lead sponsor

University Hospital Hradec Kralove is the lead sponsor of 46 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • postoperative artificial ventilation
  • serious neurological disease
  • lung disease with hypercapnia
  • propofol allergy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Desflurane Group

    Induction and anesthesia will be held by using desflurane

    Procedure: Desflurane Group

  • Experimental
    Propofol Group

    Induction and anesthesia will be held by using target-control anesthesia with propofol

    Procedure: Propofol Group

Interventions

  • ProcedureDesflurane Group

    General anesthesia will be held using desflurane in end- tidal concentration according to target value of entropy levels (between 40 and 60).

  • ProcedurePropofol Group

    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).

06

What researchers measure

Primary outcomes

  1. Visual injury

    worsening of test for visual acuity (Rodenstock)

    Time frame: 48 hours

07

Study locations

1 site
  • University Hospital Hradec Kralove
    Hradec Kralove, 50005, Czechia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03644641
Lead sponsor
University Hospital Hradec Kralove
Responsible party
Dostalova Vlasta, MD, PhD (Principal Investigator, University Hospital Hradec Kralove) — Principal investigator
First posted
Aug 23, 2018
Start date
Nov 28, 2025 (estimated)
Primary completion
Nov 30, 2028 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
May 10, 2024

Study contacts

Vlasta Dostalova, MD, Ph.D.
Contact
vlasta.dostalova@fnhk.cz
+420777883571
Pavel Dostal, MD, Ph.D.
Contact
pavel.dostal@fnhk.cz
+420495833218
Pavel Dostal, MD, Ph.D.
study director · Hradec Kralove, Czechia 50005

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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