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NCT Number: NCT03644641

The Influence of Prone Position for Spinal Surgery on Visual Acuity

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.

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Key information

Conditions

Vision; Disorder, Loss Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Desflurane Group

Procedure

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

Propofol Group

Procedure

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).

Primary outcomes

  1. Visual injury

    Time frame: 48 hours

    worsening of test for visual acuity (Rodenstock)

Study contacts

Contact information is provided by the study sponsor or research team.

Pavel Dostal, MD, Ph.D.

CONTACT

[email protected]

+420495833218

Vlasta Dostalova, MD, Ph.D.

CONTACT

[email protected]

+420777883571

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 23, 2018
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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