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

September 29, 2023 updated by: Elvan Yilmaz, Giresun University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Gi̇resun
      • Giresun, Gi̇resun, Turkey, 28100
        • Elvan Tekir Yılmaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraocular pressure
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Arterial Pressure
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
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
Heart Rate
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
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
End Tidal Carbon Dioxide (CO2)
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

January 2, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 29, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK 04/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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