Optic Nerve Sheath DiameterNCT04407715
Anesthesia on Optic Nerve Sheath Diameter
A study testing The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater in people with Optic Nerve Sheath Diameter, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Different amounts of anesthetic gas can be used in the obstetric gynecological surgery operations to be performed with open method. Researchers aimed to compare the effect of gas changes on intraocular nerve diameter by ultrasonography. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Sheath Diameter
- What is being tested?
- The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2019to 30 Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- ASA I-II
- Who underwent laparotomic gynecological surgery
Who cannot join
- Patients with obstructive pulmonary disease
- Patients with decompensated diabetes, those with a fasting period of more than 12 hours -Acute alcohol intoxication
- Chronic alcohol use
- Who refuse to participate in the study
- Who are not cooperative, do not speak Turkish
- Who had known eye disease (glaucoma, retinal detachment), had a previous history of eye surgery,
Show all 9Show fewer
- Increased intracranial pressure findings (intracranial lesion, previous cerebrovascular diseases
- Body mass index of > 40kg/m2
- ASA > III
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bursa Yüksek İhtisas Training and Research Hospital
Bursa
About this study
Official title: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery
Different amounts of anesthetic gas can be used in the obstetric gynecological surgery operations to be performed with open method. Researchers aimed to compare the effect of gas changes on intraocular nerve diameter by ultrasonography.
Read the detailed description
A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater
- Keywords
- Minimal Flow Anesthesia, Optic Nerve Sheath Diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath DiamaterProcedure or surgery
The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Anesthesia, Low Flow Anesthesia | Placebo comparator | . The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow. Group 1 (n = 40) was operated under high flow anesthesia with 50% O2 - 50% air at 2 L/min and desflurane at 1.1 MAC for the duration of the surgery. For anesthesia maintenance, Group 2 (n=40) was administered 50% oxygen - 50% air at 2 L/min and desflurane for 10-15 minutes. After reaching 1.1 MAC, it was switched to minimal flow with 50-60% oxygen- 40-50% air at 0.5 L/min and desflurane. 10 minutes before the end of the surgery, it was switched to high flow with 50% oxygen -50% air at 2 L/min. Receives: Procedure: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater |
| Peroperetive Optic Nerve Sheath Diameter | Active comparator | Optic nerve sheath diameter measurements were performed by an experienced and the same anesthetist. In the measurements, the GE Healthcare Logiq e series USG device and 12-MHz linear probe were used. Longitudinal and transverse axis images were obtained on both eyelids while the patient was in the supine position. Measurements were taken 3 mm behind the optic nerve head Receives: Procedure: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Sheath Diamater
Optic nerve sheath diamater measurements of the patients were recorded before and during the surgery at specified time points (T0: awake, T1: High fresh gas flow after induction at the 10th min., T2: Inhalation anesthesia at the 30th min., T3: Inhalation anesthesia at the 60th min., T4: Inhalation anesthesia at the 90th min., T5: Before extubation).A typical optic nerve sheath is generally less than 5 mm in diameter, and diameters greater than 5.5 mm predict an ICP of ≥20 cm H2O with 100% sensitivity and specifity
Measured: 2 hours operation time
Secondary outcomes (2)
Peroperative Complications
Complications during the surgery (decreased oxygen levels, hypercapnia, hypotension, hypertension, bradycardia, tachycardia, rhythm disorders) were recorded.
Measured: 2 hours operation time
Postoperative Complications
Complications in the recovery room (respiratory distress, decreased oxygen levels, hypotension, hypertension, bradycardia, tachycardia, vomiting, rhythm disorders) were recorded.
Measured: postop 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start30 Apr 2019
- Primary completion30 Oct 2019
- Study completion30 Dec 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anıl Onur, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Anıl Onur, MD, Principal investigator, University of Health Science Bursa Yüksek Ihtisas Training and Research HospitalH.Erkan Sayan, MD, Study director, University of Health Science Bursa Yüksek Ihtisas Training and Research HospitalTugba Onur, MD, Study chair, University of Health Science Bursa Yüksek Ihtisas Training and Research HospitalUmran Karaca, MD, Study chair, University of Health Science Bursa Yüksek Ihtisas Training and Research HospitalCanan Yılmaz, MD, Study chair, University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407715
- Sponsor's protocol ID
- 2018/11-0
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2020
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT04407715
- Acronym / sponsor ID
- 2018/11-0
- Conditions
- Optic Nerve Sheath Diameter
- Keywords
- Minimal Flow Anesthesia, Optic Nerve Sheath Diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 29 May 2020 (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.
Different amounts of anesthetic gas can be used in the obstetric gynecological surgery operations to be performed with open method. Researchers aimed to compare the effect of gas changes on intraocular nerve diameter by ultrasonography.
Detailed description
A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.
| Arm | Type | Receives |
|---|---|---|
| High Flow Anesthesia, Low Flow Anesthesia | Placebo comparator | Procedure: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater. The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow. Group 1 (n = 40) was operated under high flow anesthesia with 50% O2 - 50% air at 2 L/min and desflurane at 1.1 MAC for the duration of the surgery. For anesthesia maintenance, Group 2 (n=40) was administered 50% oxygen - 50% air at 2 L/min and desflurane for 10-15 minutes. After reaching 1.1 MAC, it was switched to minimal flow with 50-60% oxygen- 40-50% air at 0.5 L/min and desflurane. 10 minutes before the end of the surgery, it was switched to high flow with 50% oxygen -50% air at 2 L/min. |
| Peroperetive Optic Nerve Sheath Diameter | Active comparator | Procedure: The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath DiamaterOptic nerve sheath diameter measurements were performed by an experienced and the same anesthetist. In the measurements, the GE Healthcare Logiq e series USG device and 12-MHz linear probe were used. Longitudinal and transverse axis images were obtained on both eyelids while the patient was in the supine position. Measurements were taken 3 mm behind the optic nerve head |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years
- ASA I-II
- Who underwent laparotomic gynecological surgery
Key exclusion criteria (9 listed)
- Patients with obstructive pulmonary disease
- Patients with decompensated diabetes, those with a fasting period of more than 12 hours -Acute alcohol intoxication
- Chronic alcohol use
- Who refuse to participate in the study
- Who are not cooperative, do not speak Turkish
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 |
|---|---|---|
| The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath DiamaterThe patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow. | Procedure or surgery | High Flow Anesthesia, Low Flow Anesthesia, Peroperetive Optic Nerve Sheath Diameter |
Primary outcome
Optic Nerve Sheath Diamater
Time frame: 2 hours operation time
Optic nerve sheath diamater measurements of the patients were recorded before and during the surgery at specified time points (T0: awake, T1: High fresh gas flow after induction at the 10th min., T2: Inhalation anesthesia at the 30th min., T3: Inhalation anesthesia at the 60th min., T4: Inhalation anesthesia at the 90th min., T5: Before extubation).A typical optic nerve sheath is generally less than 5 mm in diameter, and diameters greater than 5.5 mm predict an ICP of ≥20 cm H2O with 100% sensitivity and specifity
2 secondary outcomes
Peroperative Complications
Time frame: 2 hours operation time
Postoperative Complications
Time frame: postop 20 minutes
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 3 Mar 2026.
- 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.
Anıl Onur, MD principal investigator
University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
H.Erkan Sayan, MD study director
University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
Tugba Onur, MD study chair
University of Health Science Bursa Yüksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater in people with Optic Nerve Sheath Diameter, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 3 inclusion and 9 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 3 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
Optic Nerve Sheath Diamater (time frame: 2 hours operation time). 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 3 Mar 2026.