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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03644641
Other study ID # UHospital Hradec Kral
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 28, 2025
Est. completion date December 30, 2029

Study information

Verified date May 2024
Source University Hospital Hradec Kralove
Contact Vlasta Dostalova, MD, Ph.D.
Phone +420777883571
Email vlasta.dostalova@fnhk.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 30, 2029
Est. primary completion date November 30, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual injury worsening of test for visual acuity (Rodenstock) 48 hours
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