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

NCT06070480 | Completed DMC

• 1 other identifier: KAEK 04/2020
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Disk Herniated Lumbar; Intraocular Pressure

Keywords

prone position; intraocular pressure; hemodynamics; anesthesia,spinal; anesthesia,general

Outcome Measures

Primary Outcomes (1)

• intraocular pressure

  Intraocular pressure was measured a total of 5 times at set time points throughout the procedures.

  Time 1:baseline supine , Time 2: 10. minute supine, Time 3: 20. minute prone , Time 4: 30. minute prone,Time 5: 10. minute after returning to the supine

Secondary Outcomes (3)

• Mean Arterial Pressure

  Time 1:baseline supine , Time 2: 10. minute supine, Time 3: 20. minute prone , Time 4: 30. minute prone,Time 5: 10. minute after returning to the supine

• Heart Rate

  Time 1:baseline supine , Time 2: 10. minute supine, Time 3: 20. minute prone , Time 4: 30. minute prone,Time 5: 10. minute after returning to the supine

• End Tidal Carbon Dioxide (CO2)

  Time 1:baseline supine , Time 2: 10. minute supine, Time 3: 20. minute prone , Time 4: 30. minute prone,Time 5: 10. minute after returning to the supine

Study Arms (3)

Spinal Anesthesia Group

ACTIVE COMPARATOR

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

Other: Spinal Anesthesia Group

Desflurane Group

ACTIVE COMPARATOR

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

Other: Desflurane Group

Propofol Group

ACTIVE COMPARATOR

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

Other: Propofol Group

Interventions

Spinal Anesthesia Group OTHER

Effect of spinal anesthesia on intraocular pressure

Spinal Anesthesia Group

Desflurane Group OTHER

Effect of general anesthesia with desflurane on intraocular pressure

Desflurane Group

Propofol Group OTHER

Effect of general anesthesia with propofol on intraocular pressure

Propofol Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Elvan Tekir Yılmaz

Giresun, Gi̇resun, 28100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 36805330 BACKGROUND

• 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.

  PMID: 25692433 RESULT

• 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.

  PMID: 25893178 RESULT

• 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.

  PMID: 29414618 RESULT

• 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.

  PMID: 38436174 DERIVED

Study Officials

• Elvan Tekir Yılmaz, M.D.

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 6, 2023
• Study Start: January 5, 2022
• Primary Completion: January 2, 2023
• Study Completion: May 15, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)