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The Influence of Prone Position for Spinal Surgery on Visual Acuity

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ClinicalTrials.gov Identifier: NCT03644641
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vision; Disorder, Loss Procedure: Desflurane Group Procedure: Propofol Group Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 28, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 30, 2022

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Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Visual injury [ Time Frame: 48 hours ]
    worsening of test for visual acuity (Rodenstock)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644641


Contacts
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Contact: Vlasta Dostalova, MD, Ph.D. +420777883571 vlasta.dostalova@fnhk.cz
Contact: Pavel Dostal, MD, Ph.D. +420495833218 pavel.dostal@fnhk.cz

Locations
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Czechia
University Hospital Hradec Kralove
Hradec Kralove, Czechia, 50005
Contact: Suchy Tomas, MD    00420495833218    suchy@fnhk.cz   
Contact: Dostal Pavel, MD, PhD    00420495832828    pavel.dostal@fnhk.cz   
Sponsors and Collaborators
University Hospital Hradec Kralove
Investigators
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Study Director: Pavel Dostal, MD, Ph.D. Hradec Kralove, Czechia 50005
More Information
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Responsible Party: Dostalova Vlasta, MD, PhD, Principal Investigator, University Hospital Hradec Kralove
ClinicalTrials.gov Identifier: NCT03644641    
Other Study ID Numbers: UHospital Hradec Kral
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove:
Desflurane
Near-infrared spectroscopy
Propofol
Spinal surgery
 Prone position
Visual acuity
Visual loss
Additional relevant MeSH terms:
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Propofol
Desflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation