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

Primary Purpose

Anesthesia, Disk Herniated Lumbar, Intraocular Pressure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal Anesthesia Group
Desflurane Group
Propofol Group
Sponsored by
Giresun University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anesthesia focused on measuring prone position, intraocular pressure, hemodynamics, anesthesia,spinal, anesthesia,general

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Elvan Tekir Yılmaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Spinal Anesthesia Group

Desflurane Group

Propofol Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean Arterial Pressure
Mean Arterial Pressure was measured a total of 5 times at set time points throughout the procedures.
Heart Rate
Heart Rate was measured a total of 5 times at set time points throughout the procedures.
End Tidal Carbon Dioxide (CO2)
End Tidal CO2 was measured a total of 5 times at set time points throughout the procedures.

Full Information

First Posted
September 18, 2023
Last Updated
September 29, 2023
Sponsor
Giresun University
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1. Study Identification

Unique Protocol Identification Number
NCT06070480
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 2, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Giresun University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Disk Herniated Lumbar, Intraocular Pressure
Keywords
prone position, intraocular pressure, hemodynamics, anesthesia,spinal, anesthesia,general

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Anesthesia Group
Arm Type
Active Comparator
Arm Description
Intraocular pressure values of the patients operated with spinal anaesthesia were measured
Arm Title
Desflurane Group
Arm Type
Active Comparator
Arm Description
Intraocular pressure values were measured in patients operated under general anaesthesia with desflurane.
Arm Title
Propofol Group
Arm Type
Active Comparator
Arm Description
Intraocular pressure values were measured in patients operated under general anaesthesia with desflurane.
Intervention Type
Other
Intervention Name(s)
Spinal Anesthesia Group
Intervention Description
Effect of spinal anesthesia on intraocular pressure
Intervention Type
Other
Intervention Name(s)
Desflurane Group
Intervention Description
Effect of general anesthesia with desflurane on intraocular pressure
Intervention Type
Other
Intervention Name(s)
Propofol Group
Intervention Description
Effect of general anesthesia with propofol on intraocular pressure
Primary Outcome Measure Information:
Title
intraocular pressure
Description
Intraocular pressure was measured a total of 5 times at set time points throughout the procedures.
Time Frame
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 Outcome Measure Information:
Title
Mean Arterial Pressure
Description
Mean Arterial Pressure was measured a total of 5 times at set time points throughout the procedures.
Time Frame
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
Title
Heart Rate
Description
Heart Rate was measured a total of 5 times at set time points throughout the procedures.
Time Frame
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
Title
End Tidal Carbon Dioxide (CO2)
Description
End Tidal CO2 was measured a total of 5 times at set time points throughout the procedures.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elvan Tekir Yılmaz, M.D.
Organizational Affiliation
Giresun University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elvan Tekir Yılmaz
City
Giresun
State/Province
Gi̇resun
ZIP/Postal Code
28100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36805330
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.
Results Reference
background
PubMed Identifier
25692433
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.
Results Reference
result
PubMed Identifier
25893178
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.
Results Reference
result
PubMed Identifier
29414618
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.
Results Reference
result

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

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