NCT03644641

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Nov 2025Dec 2029

First Submitted

Initial submission to the registry

August 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
7.3 years until next milestone

Study Start

First participant enrolled

November 28, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2029

Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

August 21, 2018

Last Update Submit

May 9, 2024

Conditions

Vision; Disorder, Loss

Keywords

DesfluraneNear-infrared spectroscopyPropofolSpinal surgeryProne positionVisual acuityVisual loss

Outcome Measures

Primary Outcomes (1)

  • Visual injury

    worsening of test for visual acuity (Rodenstock)

    48 hours

Study Arms (2)

Desflurane Group

EXPERIMENTAL

Induction and anesthesia will be held by using desflurane

Procedure: Desflurane Group

Propofol Group

EXPERIMENTAL

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

Procedure: Propofol Group

Interventions

Desflurane GroupPROCEDURE

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

Desflurane Group
Propofol GroupPROCEDURE

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).

Propofol Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pavel Dostal, MD, Ph.D.

    Hradec Kralove, Czechia 50005

    STUDY DIRECTOR

Central Study Contacts

Vlasta Dostalova, MD, Ph.D.

CONTACT

+420777883571vlasta.dostalova@fnhk.cz

Pavel Dostal, MD, Ph.D.

CONTACT

+420495833218pavel.dostal@fnhk.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 23, 2018

Study Start

November 28, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 30, 2029

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

CZ(1)