The Influence of Prone Position for Spinal Surgery on Visual Acuity

May 9, 2024 updated by: Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Hradec Kralove, Czechia, 50005
        • University hospital Hradec Králové
        • Contact:
          • Suchy Tomas, MD
          • Phone Number: 00420495833218
          • Email: suchy@fnhk.cz
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane Group
Induction and anesthesia will be held by using desflurane
Procedure: Desflurane Group
General anesthesia will be held using desflurane in end- tidal concentration according to target value of entropy levels (between 40 and 60).
Experimental: Propofol Group
Induction and anesthesia will be held by using target-control anesthesia with propofol
Procedure: Propofol 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual injury
Time Frame: 48 hours
worsening of test for visual acuity (Rodenstock)
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Hradec Kralove

Investigators

  • Study Director: Pavel Dostal, MD, Ph.D., Hradec Kralove, Czechia 50005

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 28, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHospital Hradec Kral

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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