AnesthesiaNCT06070480
Effects of Different Types of Anaesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery
A study testing Spinal Anesthesia Group, Desflurane Group and Propofol Group in people with Anesthesia and Disk Herniated Lumbar, run by Giresun University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Disk Herniated Lumbar, Intraocular Pressure
- What is being tested?
- Spinal Anesthesia Group, Desflurane Group and Propofol Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2 according to the American Society of Anesthesiologists (ASA) Classification.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Disk Herniated Lumbar, Intraocular Pressure
- Being tested
- Spinal Anesthesia Group, Desflurane Group, Propofol Group
- Keywords
- prone position, intraocular pressure, hemodynamics, anesthesia,spinal, anesthesia,general
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia GroupOther
Effect of spinal anesthesia on intraocular pressure
Desflurane GroupOther
Effect of general anesthesia with desflurane on intraocular pressure
Propofol GroupOther
Effect of general anesthesia with propofol on intraocular pressure
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia Group | Active comparator | Intraocular pressure values of the patients operated with spinal anaesthesia were measured Receives: Other: Spinal Anesthesia Group |
| Desflurane Group | Active comparator | Intraocular pressure values were measured in patients operated under general anaesthesia with desflurane. Receives: Other: Desflurane Group |
| Propofol Group | Active comparator | Intraocular pressure values were measured in patients operated under general anaesthesia with desflurane. Receives: Other: Propofol Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
Intraocular pressure was measured a total of 5 times at set time points throughout the procedures.
Measured: 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 (3)
Mean Arterial Pressure
Mean Arterial Pressure was measured a total of 5 times at set time points throughout the procedures.
Measured: 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
Heart Rate was measured a total of 5 times at set time points throughout the procedures.
Measured: 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)
End Tidal CO2 was measured a total of 5 times at set time points throughout the procedures.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start5 Jan 2022
- Primary completion2 Jan 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvan Yilmaz, Giresun University
- Investigators
- Elvan Tekir Yılmaz, M.D., Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070480
- Sponsor's protocol ID
- KAEK 04/2020
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36805330Kwee 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.
PubMed 25692433DePasse 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.
PubMed 25893178Pinar 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.
PubMed 29414618Yilmaz ET, Keles BO. Effects of propofol, desflurane, and spinal anesthesia on intraocular pressure during lumbar disc herniation surgery: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2024 Feb;28(4):1407-1416. doi: 10.26355/eurrev_202402_35462.
PubMed 38436174
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Propofol, Desflurane and Spinal Anesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06070480
- Acronym / sponsor ID
- KAEK 04/2020
- Conditions
- Anesthesia, Disk Herniated Lumbar, Intraocular Pressure
- Keywords
- prone position, intraocular pressure, hemodynamics, anesthesia,spinal, anesthesia,general
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia Group | Active comparator | Other: Spinal Anesthesia GroupIntraocular pressure values of the patients operated with spinal anaesthesia were measured |
| Desflurane Group | Active comparator | Other: Desflurane GroupIntraocular pressure values were measured in patients operated under general anaesthesia with desflurane. |
| Propofol Group | Active comparator | Other: Propofol GroupIntraocular pressure values were measured in patients operated under general anaesthesia with desflurane. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2 according to the American Society of Anesthesiologists (ASA) Classification.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Anesthesia GroupEffect of spinal anesthesia on intraocular pressure | Other | Spinal Anesthesia Group |
| Desflurane GroupEffect of general anesthesia with desflurane on intraocular pressure | Other | Desflurane Group |
| Propofol GroupEffect of general anesthesia with propofol on intraocular pressure | Other | Propofol Group |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 36805330Cunha 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 publication: PubMed 25692433Kwee 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 publication: PubMed 25893178DePasse 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 publication: PubMed 29414618Pinar 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.
- Derived from this study: PubMed 38436174Yilmaz ET, Keles BO. Effects of propofol, desflurane, and spinal anesthesia on intraocular pressure during lumbar disc herniation surgery: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2024 Feb;28(4):1407-1416. doi: 10.26355/eurrev_202402_35462.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvan Tekir Yılmaz, M.D. principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia Group, Desflurane Group and Propofol Group in people with Anesthesia and Disk Herniated Lumbar, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06070480, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.