The Influence of Prone Position for Spinal Surgery on Visual Acuity

NCT ID: NCT03644641

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2029-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vision; Disorder, Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Desflurane Group

Induction and anesthesia will be held by using desflurane

Group Type EXPERIMENTAL

Desflurane Group

Intervention Type 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

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

Group Type EXPERIMENTAL

Propofol Group

Intervention Type 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).

Interventions

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Desflurane Group

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

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Hradec Kralove

OTHER

Sponsor Role lead

Responsible Party

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Dostalova Vlasta, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pavel Dostal, MD, Ph.D.

Role: STUDY_DIRECTOR

Hradec Kralove, Czechia 50005

Locations

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University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Vlasta Dostalova, MD, Ph.D.

Role: CONTACT

+420777883571

Pavel Dostal, MD, Ph.D.

Role: CONTACT

+420495833218

Facility Contacts

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Suchy Tomas, MD

Role: primary

00420495833218

Dostal Pavel, MD, PhD

Role: backup

00420495832828

Other Identifiers

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UHospital Hradec Kral

Identifier Type: -

Identifier Source: org_study_id

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