Effects of Different Types of Anaesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery

NCT ID: NCT06070480

Last Updated: 2023-10-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2023-05-15

Brief Summary

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The aim of this study was to investigate the effects of anaesthesia methods on intraocular pressure during lumbar disc surgery performed in the prone position.

Detailed Description

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The study included 75 patients with lumbar disc herniation between the ages of 18-75, with the American Society of Anesthesiologists (ASA) 1-2. The patients were randomly divided into 3 groups: propofol, desflurane, spinal. Intraocular pressure (IOP) was measured at 5 time points throughout surgery, including baseline (T1), 10 minutes after anesthesia (T2), 10 minutes after prone positioning (T3: early prone), 30 minutes after prone positioning (T4: late prone), and 10 minutes after returning to the supine position (T5). Hemodynamic parameters were measured at these time points. Hemoglobin and hematocrit values were measured preoperatively and on the first postoperative day.

Conditions

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Anesthesia Disk Herniated Lumbar Intraocular Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study included 75 patients with lumbar disc herniation between the ages of 18-75, with the American Society of Anesthesiologists (ASA) 1-2. The patients were randomly divided into 3 groups: propofol, desflurane, spinal. Intraocular pressure was measured at 5 time points throughout surgery, including baseline (T1), 10 minutes after anesthesia (T2), 10 minutes after prone positioning (T3: early prone), 30 minutes after prone positioning (T4: late prone), and 10 minutes after returning to the supine position (T5). Hemodynamic parameters were measured at these time points. Hemoglobin and hematocrit values were measured preoperatively and on the first postoperative day.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spinal Anesthesia Group

Intraocular pressure values of the patients operated with spinal anaesthesia were measured

Group Type ACTIVE_COMPARATOR

Spinal Anesthesia Group

Intervention Type OTHER

Effect of spinal anesthesia on intraocular pressure

Desflurane Group

Intraocular pressure values were measured in patients operated under general anaesthesia with desflurane.

Group Type ACTIVE_COMPARATOR

Desflurane Group

Intervention Type OTHER

Effect of general anesthesia with desflurane on intraocular pressure

Propofol Group

Intraocular pressure values were measured in patients operated under general anaesthesia with desflurane.

Group Type ACTIVE_COMPARATOR

Propofol Group

Intervention Type OTHER

Effect of general anesthesia with propofol on intraocular pressure

Interventions

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Spinal Anesthesia Group

Effect of spinal anesthesia on intraocular pressure

Intervention Type OTHER

Desflurane Group

Effect of general anesthesia with desflurane on intraocular pressure

Intervention Type OTHER

Propofol Group

Effect of general anesthesia with propofol on intraocular pressure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA 1-2 according to the American Society of Anesthesiologists (ASA) Classification.

Exclusion Criteria

* Who did not sign the informed consent form,
* patients who required emergency surgery,
* eye surgery recipients,
* subjects with acute or chronic eye diseases other than refractive errors,
* individuals detected to have elevated IOP in preoperative measurements
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Elvan Yilmaz

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elvan Tekir Yılmaz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Giresun University

Locations

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Elvan Tekir Yılmaz

Giresun, Gi̇resun, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Cunha PD, Barbosa TP, Correia G, Silva R, Cruz Oliveira N, Varanda P, Direito-Santos B. The ideal patient positioning in spine surgery: a preventive strategy. EFORT Open Rev. 2023 Feb 21;8(2):63-72. doi: 10.1530/EOR-22-0135.

Reference Type BACKGROUND
PMID: 36805330 (View on PubMed)

Kwee MM, Ho YH, Rozen WM. The prone position during surgery and its complications: a systematic review and evidence-based guidelines. Int Surg. 2015 Feb;100(2):292-303. doi: 10.9738/INTSURG-D-13-00256.1.

Reference Type RESULT
PMID: 25692433 (View on PubMed)

DePasse JM, Palumbo MA, Haque M, Eberson CP, Daniels AH. Complications associated with prone positioning in elective spinal surgery. World J Orthop. 2015 Apr 18;6(3):351-9. doi: 10.5312/wjo.v6.i3.351. eCollection 2015 Apr 18.

Reference Type RESULT
PMID: 25893178 (View on PubMed)

Pinar HU, Kasdogan ZEA, Basaran B, Coven I, Karaca O, Dogan R. The effect of spinal versus general anesthesia on intraocular pressure in lumbar disc surgery in the prone position: A randomized, controlled clinical trial. J Clin Anesth. 2018 May;46:54-58. doi: 10.1016/j.jclinane.2018.01.026. Epub 2018 Mar 26.

Reference Type RESULT
PMID: 29414618 (View on PubMed)

Yilmaz ET, Keles BO. Effects of propofol, desflurane, and spinal anesthesia on intraocular pressure during lumbar disc herniation surgery: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2024 Feb;28(4):1407-1416. doi: 10.26355/eurrev_202402_35462.

Reference Type DERIVED
PMID: 38436174 (View on PubMed)

Other Identifiers

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KAEK 04/2020

Identifier Type: -

Identifier Source: org_study_id

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