Optic Nerve Sheath DiameterNCT04427085
Changes of Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery
A study testing Ultrasound assessment of optic nerve sheath diameter in people with Optic Nerve Sheath Diameter, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
This study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Optic Nerve Sheath Diameter
- What is being tested?
- Ultrasound assessment of optic nerve sheath diameter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2020to 24 May 2022
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic gynecological surgery
Who cannot join
- Ophthalmic diseases
- Previous history of ophthalmic surgery.
- Neurological disorders
- History of head surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery
This study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.
- Conditions
- Optic Nerve Sheath Diameter
- Being tested
- Ultrasound assessment of optic nerve sheath diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessment of optic nerve sheath diameterOther
Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Experimental | body mass index≥ 30 kg/m2 Receives: Other: Ultrasound assessment of optic nerve sheath diameter |
| Non-obese group | Active comparator | BMI < 30 kg/m2 Receives: Other: Ultrasound assessment of optic nerve sheath diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured.
Measured: 30 minutes after pneuroperitoneum in the Trendelenburg position
Secondary outcomes (9)
Optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured.
Measured: 15 minutes after pneuroperitoneum in the Trendelenburg position
Optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured.
Measured: 60 minutes after pneuroperitoneum in the Trendelenburg position
Optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured.
Measured: 10 minutes after release of pneumoperitoneum and return to the supine position
Optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured.
Measured: At 1 hour after completion of surgery
Optic nerve sheath diameter
Using ultrasonography, optic nerve sheath diameter is measured.
Measured: At 24 hours after completion of surgery
Nausea and vomiting
The presence and severity of nausea and vomiting is evaluated.
Measured: At 1 hour after completion of surgery
Headache
The presence and severity of headache is evaluated.
Measured: At 1 hour after completion of surgery
Nausea and vomiting
The presence and severity of nausea and vomiting is evaluated.
Measured: At 24 hours after completion of surgery
Headache
The presence and severity of headache is evaluated.
Measured: At 24 hours after completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start3 Aug 2020
- Primary completion23 May 2022
- Study completion24 May 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 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
- NCT04427085
- Sponsor's protocol ID
- 20421
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2020
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Sheath Diameter Between Obese and Non-obese Patients Undergoing Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT04427085
- Acronym / sponsor ID
- 20421
- Conditions
- Optic Nerve Sheath Diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 11 Jun 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.
This study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep Trendelenburg position.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | Experimental | Other: Ultrasound assessment of optic nerve sheath diameterbody mass index≥ 30 kg/m2 |
| Non-obese group | Active comparator | Other: Ultrasound assessment of optic nerve sheath diameterBMI < 30 kg/m2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic gynecological surgery
Key exclusion criteria (4 listed)
- Ophthalmic diseases
- Previous history of ophthalmic surgery.
- Neurological disorders
- History of head surgery.
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 assessment of optic nerve sheath diameterUsing ultrasonography, optic nerve sheath diameter is measured during perioperative period. | Other | Non-obese group, Obese group |
Primary outcome
Optic nerve sheath diameter
Time frame: 30 minutes after pneuroperitoneum in the Trendelenburg position
Using ultrasonography, optic nerve sheath diameter is measured.
9 secondary outcomes
Optic nerve sheath diameter
Time frame: 15 minutes after pneuroperitoneum in the Trendelenburg position
Optic nerve sheath diameter
Time frame: 60 minutes after pneuroperitoneum in the Trendelenburg position
Optic nerve sheath diameter
Time frame: 10 minutes after release of pneumoperitoneum and return to the supine position
Optic nerve sheath diameter
Time frame: At 1 hour after completion of surgery
Optic nerve sheath diameter
Time frame: At 24 hours after completion of surgery
Nausea and vomiting
Time frame: At 1 hour after completion of surgery
Headache
Time frame: At 1 hour after completion of surgery
Nausea and vomiting
Time frame: At 24 hours after completion of surgery
Headache
Time frame: At 24 hours after completion of 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 26 Jun 2024.
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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?
A study testing Ultrasound assessment of optic nerve sheath diameter in people with 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 4 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 26 Jun 2024. 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?
Optic nerve sheath diameter (time frame: 30 minutes after pneuroperitoneum in the Trendelenburg position). 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 26 Jun 2024.