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

Sponsor
Giresun University (Other)
Overall Status
Completed
CT.gov ID
NCT06070480
Collaborator
(none)
75
1
3
16.3
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Spinal Anesthesia Group
  • Other: Desflurane Group
  • Other: Propofol Group
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Diagnostic
Official Title:
Effects of Propofol, Desflurane and Spinal Anesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery: A Randomized Controlled Study
Actual Study Start Date :
Jan 5, 2022
Actual Primary Completion Date :
Jan 2, 2023
Actual Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Spinal Anesthesia Group

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

Other: Spinal Anesthesia Group
Effect of spinal anesthesia on intraocular pressure

Active Comparator: Desflurane Group

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

Other: Desflurane Group
Effect of general anesthesia with desflurane on intraocular pressure

Active Comparator: Propofol Group

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

Other: Propofol Group
Effect of general anesthesia with propofol on intraocular pressure

Outcome Measures

Primary Outcome Measures

  1. intraocular 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]

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

Secondary Outcome Measures

  1. 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]

    Mean Arterial Pressure was measured a total of 5 times at set time points throughout the procedures.

  2. 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]

    Heart Rate was measured a total of 5 times at set time points throughout the procedures.

  3. 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]

    End Tidal CO2 was measured a total of 5 times at set time points throughout the procedures.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Elvan Tekir Yılmaz Giresun Gi̇resun Turkey 28100

Sponsors and Collaborators

  • Giresun University

Investigators

  • Principal Investigator: Elvan Tekir Yılmaz, M.D., Giresun University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elvan Yilmaz, Assistant professor, Giresun University
ClinicalTrials.gov Identifier:
NCT06070480
Other Study ID Numbers:
  • KAEK 04/2020
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elvan Yilmaz, Assistant professor, Giresun University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023