Clinical trial NCT06070480: Effects of Different Types of Anaesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery
Official title: Effects of Propofol, Desflurane and Spinal Anesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Disk Herniated Lumbar
Intraocular Pressure
Keywords: prone position
intraocular pressure
hemodynamics
anesthesia,spinal
anesthesia,general
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 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 purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: intraocular pressure
timeFrame: 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:
measure: Mean Arterial Pressure
timeFrame: 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
measure: Heart Rate
timeFrame: 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
measure: End Tidal Carbon Dioxide (CO2)
timeFrame: 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
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Elvan Tekir Yılmaz
state: Gi̇resun
Study officials:
affiliation: Giresun University
name: Elvan Tekir Yılmaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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. doi: 10.1016/j.jclinane.2018.01.026. Epub 2018 Mar 26.