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

Anesthesia Clinical Trial

Official title:

Effects of Propofol, Desflurane and Spinal Anesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06070480
• Other study ID #: KAEK 04/2020
• Status: Completed
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: September 2023
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 15, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Disk Herniated Lumbar
• Intervertebral Disc Displacement
• Intraocular Pressure

Intervention

Other:
• Spinal Anesthesia Group
Effect of spinal anesthesia on intraocular pressure
• Desflurane Group
Effect of general anesthesia with desflurane on intraocular pressure
• Propofol Group
Effect of general anesthesia with propofol on intraocular pressure

Locations

Country	Name	City	State
Turkey	Elvan Tekir Yilmaz	Giresun	Gi?resun

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Arterial Pressure	Mean Arterial 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	Heart Rate	Heart Rate 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	End Tidal Carbon Dioxide (CO2)	End Tidal CO2 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