Optic Nerve Sheath DiameterNCT04955925
Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter
An observational study of Optic Nerve Sheath Diameter, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Optic Nerve Sheath Diameter
- What is being tested?
- Ultrasound examination of the optic nerve sheath diameter
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jul 2021to 18 Aug 2022
- Phase
- Observational
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing middle ear surgery under general anesthesia
Who may be able to join
- Patients undergoing middle ear surgery
Who cannot join
- History of cerebrovascular diseases
- Increased intracranial pressure
- History of ophthalmic surgery or diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter in Patients Undergoing Middle Ear Surgery
In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery.
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- Ultrasound examination of the optic nerve sheath diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination of the optic nerve sheath diameterDiagnostic test
The optic nerve sheath diameter is examined using ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Anesthesia is maintained with sevoflurane during the surgery. Receives: Diagnostic Test: Ultrasound examination of the optic nerve sheath diameter | |
| Propofol group | Anesthesia is maintained with total venous anesthesia using propofol during the surgery. Receives: Diagnostic Test: Ultrasound examination of the optic nerve sheath diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the optic nerve sheath diameter
The optic nerve sheath of each eye is observed using ultrasound, and the optic nerve sheath diameter is assessed after induction of anesthesia and at the end of surgery.
Measured: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
Secondary outcomes (2)
Optic nerve sheath diameter at each time point
The optic nerve sheath of each eye is observed using ultrasound, and the optic nerve sheath diameter is assessed after induction of anesthesia and at the end of surgery.
Measured: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
Nausea and vomiting
Presence and severity of nausea and vomiting is assessed.
Measured: At 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start26 Jul 2021
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve Sheath DiameterStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955925
- Sponsor's protocol ID
- 03-2020
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Sevoflurane and Propofol on the Optic Nerve Sheath Diameter in Patients Undergoing Middle Ear Surgery
- ClinicalTrials.gov ID
- NCT04955925
- Acronym / sponsor ID
- 03-2020
- Conditions
- Optic Nerve Sheath Diameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 9 Jul 2021 (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.
In the present study, we compare the effect of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing middle ear surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | – | Diagnostic Test: Ultrasound examination of the optic nerve sheath diameterAnesthesia is maintained with sevoflurane during the surgery. |
| Propofol group | – | Diagnostic Test: Ultrasound examination of the optic nerve sheath diameterAnesthesia is maintained with total venous anesthesia using propofol during the surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing middle ear surgery under general anesthesia
Key inclusion criteria (1 listed)
- Patients undergoing middle ear surgery
Key exclusion criteria (3 listed)
- History of cerebrovascular diseases
- Increased intracranial pressure
- History of ophthalmic surgery or diseases
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 |
|---|---|---|
| Ultrasound examination of the optic nerve sheath diameterThe optic nerve sheath diameter is examined using ultrasonography. | Diagnostic test | Propofol group, Sevoflurane group |
Primary outcome
Change of the optic nerve sheath diameter
Time frame: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
The optic nerve sheath of each eye is observed using ultrasound, and the optic nerve sheath diameter is assessed after induction of anesthesia and at the end of surgery.
2 secondary outcomes
Optic nerve sheath diameter at each time point
Time frame: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery
Nausea and vomiting
Time frame: At 1 hour after surgery
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 17 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Nerve Sheath Diameter, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
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 3 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 17 Mar 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 South Korea. 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?
Change of the optic nerve sheath diameter (time frame: At 1 minute after the induction of anesthesia and at 1 minute after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.