Optic Nerve CupNCT06464419
Effect of Lithotomy Position on Optic Nerve Sheath Diameter
An observational study of Optic Nerve Cup and Intracranial Pressure Increase, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of increased venous return and increased intra-abdominal pressure on intracranial pressure in the lithotomy position was evaluated. 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 Cup, Intracranial Pressure Increase
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 1 Sep 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 52 patients, ASA I-II, aged between 18-65, who are scheduled for elective RIRS surgery under general anesthesia will be included.
Who may be able to join
- Patients who give informed consent
- Patients who will undergo retrograde intrarenal surgery
- Patients who are fully oriented and cooperative
- ASA I-II patients
- Patients between the ages of 18-65
Who cannot join
- Disoriented and uncooperative patients
- Patients with BMI>30
- Patients who have had previous intracranial surgery
- Patients who have had eye surgery before
- Patients allergic to the pharmacological agents used in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
EtlikCityHospital
Ankara
Cansu Ekici, +90 5322036054, cansugun00@gmail.com
About this study
Official title: Ultrasonographic Evaluation of Optic Nerve Sheath Diameter in Patients Undergoing Retrograde Intrarenal Surgery in the Lithotomy Position
In this study, the effect of increased venous return and increased intra-abdominal pressure on intracranial pressure in the lithotomy position was evaluated.
Read the detailed description
In the lithotomy position, it is possible that venous return in the lower extremities increases and intra-abdominal pressure increases due to the position. At the same time, it is possible that the intracompartmental pressure in the extremities increases because the venous structure is compressed by placing the lower extremities on supports. Considering both conditions, it is predicted that there may be an increase in the optic nerve sheath diameter due to increased intracranial pressure in patients placed in the lithotomy position. The aim of this study is to investigate the effect of the position on intracranial pressure by ultrasonographically evaluating the optic nerve sheath diameter in the lithotomy position.
- Conditions
- Optic Nerve Cup, Intracranial Pressure Increase
- Being tested
- ultrasound
- Keywords
- ultrasonography, lithotomy position
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
Measurement of optic nerve sheath diameter by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Patients who will undergo RIRS surgery | Patients who will undergo RIRS surgery in the lithotomy position Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of lithotomy position on optic nerve sheath diameter
In patients in the lithotomy position, the linear probe of the ultrasound will be placed on the patient's upper eyelid in a transverse and longitudinal manner without applying compression, and the optic nerve's entry into the orbit will be visualized and measured. The increase in the optic nerve sheath diameter will be recorded by measuring at 7 different times in total.Before general anesthesia (t1), 3 minutes (min.) (t2) and 5 min. (t3) after general anesthesia, 3 min. (t4) and 5 min. (t5) after lithotomy position was given, before lithotomy position was corrected (t6) and when 10 minutes after patients go to the recovery room (t7).
Measured: intraoperative and postoperative 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start10 Jun 2024
- Primary completion10 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Optic Nerve CupStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Sponsor
- Investigators
- Cansu Ekici, Study director, EtlikCityHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464419
- Sponsor's protocol ID
- 14408
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Publications
Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.
PubMed 25955869Besir A, Tugcugil E. Effects of tourniquet usage in lower extremity surgery on optic nerve sheath diameter. Turk J Med Sci. 2018 Oct 31;48(5):980-984. doi: 10.3906/sag-1803-132.
PubMed 30384564Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
PubMed 28284189
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Optic Nerve Sheath Diameter in Patients Undergoing Retrograde Intrarenal Surgery in the Lithotomy Position
- ClinicalTrials.gov ID
- NCT06464419
- Acronym / sponsor ID
- 14408
- Conditions
- Optic Nerve Cup, Intracranial Pressure Increase
- Keywords
- ultrasonography, lithotomy position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 Jun 2024 (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 this study, the effect of increased venous return and increased intra-abdominal pressure on intracranial pressure in the lithotomy position was evaluated.
Detailed description
In the lithotomy position, it is possible that venous return in the lower extremities increases and intra-abdominal pressure increases due to the position. At the same time, it is possible that the intracompartmental pressure in the extremities increases because the venous structure is compressed by placing the lower extremities on supports. Considering both conditions, it is predicted that there may be an increase in the optic nerve sheath diameter due to increased intracranial pressure in patients placed in the lithotomy position. The aim of this study is to investigate the effect of the position on intracranial pressure by ultrasonographically evaluating the optic nerve sheath diameter in the lithotomy position.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who will undergo RIRS surgery | – | Device: ultrasoundPatients who will undergo RIRS surgery in the lithotomy position |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 52 patients, ASA I-II, aged between 18-65, who are scheduled for elective RIRS surgery under general anesthesia will be included.
Key inclusion criteria (5 listed)
- Patients who give informed consent
- Patients who will undergo retrograde intrarenal surgery
- Patients who are fully oriented and cooperative
- ASA I-II patients
- Patients between the ages of 18-65
Key exclusion criteria (5 listed)
- Disoriented and uncooperative patients
- Patients with BMI>30
- Patients who have had previous intracranial surgery
- Patients who have had eye surgery before
- Patients allergic to the pharmacological agents used in the study
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 |
|---|---|---|
| ultrasoundMeasurement of optic nerve sheath diameter by ultrasound | Device | Patients who will undergo RIRS surgery |
Primary outcome
Effect of lithotomy position on optic nerve sheath diameter
Time frame: intraoperative and postoperative 10 minutes
In patients in the lithotomy position, the linear probe of the ultrasound will be placed on the patient's upper eyelid in a transverse and longitudinal manner without applying compression, and the optic nerve's entry into the orbit will be visualized and measured. The increase in the optic nerve sheath diameter will be recorded by measuring at 7 different times in total.Before general anesthesia (t1), 3 minutes (min.) (t2) and 5 min. (t3) after general anesthesia, 3 min. (t4) and 5 min. (t5) after lithotomy position was given, before lithotomy position was corrected (t6) and when 10 minutes after patients go to the recovery room (t7).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Results publication: PubMed 25955869Maissan IM, Dirven PJ, Haitsma IK, Hoeks SE, Gommers D, Stolker RJ. Ultrasonographic measured optic nerve sheath diameter as an accurate and quick monitor for changes in intracranial pressure. J Neurosurg. 2015 Sep;123(3):743-7. doi: 10.3171/2014.10.JNS141197. Epub 2015 May 8.
- Results publication: PubMed 30384564Besir A, Tugcugil E. Effects of tourniquet usage in lower extremity surgery on optic nerve sheath diameter. Turk J Med Sci. 2018 Oct 31;48(5):980-984. doi: 10.3906/sag-1803-132.
- Results publication: PubMed 28284189Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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.
Cansu Ekici study director
EtlikCityHospital
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 Cup and Intracranial Pressure Increase, run by Başakşehir Çam & Sakura City 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 5 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: status not confirmed, as of the sponsor's last update on 5 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cansu Ekici (+905322036054, cansugun00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of lithotomy position on optic nerve sheath diameter (time frame: intraoperative and postoperative 10 minutes). 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 NCT06464419, which also lists 3 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 5 Aug 2024.