INTRACRANIAL TUMORNCT06559566
Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery
A study testing USG and BCT in people with INTRACRANIAL TUMOR and INTRACRANIAL PRESSURE, run by Sezen Kumaş Solak.
Trial summary
Ultrasonography(USG)-guided optic nerve sheath diameter measurement and its correlation with brain computed tomography in the evaluation of intracranial pressure in patients who underwent intracranial brain tumor surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- INTRACRANIAL TUMOR, INTRACRANIAL PRESSURE, OPTIC NERVE
- What is being tested?
- USG and BCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 1 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 -65 years
- Brain malignant neoplasm tumor
- Brain benign neoplasm supratentorial
- Brain benign neoplasm infratentorial information
Who cannot join
- Patients who cannot provide adequate image quality in ocular ultrasonography
- Who are unconscious or have a Glasgow coma scale of less than 15
- Pseudotumor cerebri
- Optic nerve arachnoid cyst
- Patients with open injuries involving the eyelid and surrounding area
- Optic nerve malignant neoplasm
Show all 11Show fewer
- Injury of the optic nerve and its pathways
- Systemic Lupus Erythematosis,
- Scleroderma
- Multiple Sclerosis, sarcoidosis
- Thyrotoxicosis (hyperthyroidism)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Two Methods Used to Asses Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery
Ultrasonography(USG)-guided optic nerve sheath diameter measurement and its correlation with brain computed tomography in the evaluation of intracranial pressure in patients who underwent intracranial brain tumor surgery.
Read the detailed description
Optic Nerve Sheath Diameter (ONSD) Measurement is a non-invasive diagnostic method used to detect increased intracranial pressure, and in general, ONSD measurement over 5 mm has been found to be associated with increased intracranial pressure.ONSD will be measured using an USG device within the specified time periods.
T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection
ONSD measurement in brain computer tomography (BCT); Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded.In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).
T0: ONSD measurement in pre-operative Brain CT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period
- Conditions
- INTRACRANIAL TUMOR, INTRACRANIAL PRESSURE, OPTIC NERVE
- Being tested
- USG, BCT
- Keywords
- OPTIC NERVE, INTRACRANIAL PRESSURE, INTRACRANIAL TUMOR, INTRACRANIAL TUMOR SURGERY, Intracranial Pressure Change
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USGProcedure or surgery
Also called ONSD measurement with USG
The aim of this study is to measure the intracranial pressure of patients planned for brain tumor surgery by measuring the optic nerve sheath diameter (ONSD) under USG guidance and compare its correlation with the computed brain tomography.
BCTProcedure or surgery
Also called ONSD measurement with BCT
The aim of this study is to measure the intracranial pressure of patients planned for brain tumor surgery by measuring the optic nerve sheath diameter (ONSD) under USG guidance and compare its correlation with the computed brain tomography.
| Study group | Role | What they receive |
|---|---|---|
| ONSD measurement with USG | Active comparator | After the ONSD measurement is made before anesthesia induction, general anesthesia will be given to each patient according to the institutional protocol. The ONSD measurements of the patients will be measured according to the T0, T1, T2, T3, T4, T5 time period by a person who has experience in using USG T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection Receives: Procedure: USG |
| ONSD measurement with BCT | Active comparator | In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).
T0: ONSD measurement in pre-operative BCT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period The measurement of ONSD in BCT is; Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded. Receives: Procedure: BCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial pressure
To compare the optic nerve diameter measurement ,USG and BBT values used to measure intracranial pressure in patients with brain tumor surgery
Measured: T0: Before anesthesia induction T1: peroperative5. minutes T2: At the end of the surgery 6.hours T3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
Secondary outcomes (2)
Heart Rate
To compare the heart rate measurement
Measured: T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hoursT3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
Blood pressure
To compare the blood pressure measurement
Measured: T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hours T3 extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (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 INTRACRANIAL TUMORStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sezen Kumaş Solak
- Sponsor type
- Other government
- Collaborators
- Bagcilar Training and Research Hospital
- Responsible party
- Sponsor-investigator, Sezen Kumaş Solak, Bagcilar Training and Research Hospital
- Investigators
- SEZEN KUMAS SOLAK, MD, Principal investigator, Bagcılar Training Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559566
- Sponsor's protocol ID
- BAGCILAR 3
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual patient data
Publications
Stevens RRF, Gommer ED, Aries MJH, Ertl M, Mess WH, Huberts W, Delhaas T. Optic nerve sheath diameter assessment by neurosonology: A review of methodologic discrepancies. J Neuroimaging. 2021 Sep;31(5):814-825. doi: 10.1111/jon.12906. Epub 2021 Jul 16.
PubMed 34270144Raffiz M, Abdullah JM. Optic nerve sheath diameter measurement: a means of detecting raised ICP in adult traumatic and non-traumatic neurosurgical patients. Am J Emerg Med. 2017 Jan;35(1):150-153. doi: 10.1016/j.ajem.2016.09.044. Epub 2016 Sep 23.
PubMed 27852525Xu J, Song Y, Shah Nayaz BM, Shi W, Zhao Y, Liu Y, Wu S, Li Z, Sun Y, Zhao Y, Yu W, Wang X. Optic Nerve Sheath Diameter Sonography for the Diagnosis of Intracranial Hypertension in Traumatic Brain Injury: A Systematic Review and Meta-Analysis. World Neurosurg. 2024 Feb;182:136-143. doi: 10.1016/j.wneu.2023.11.016. Epub 2023 Nov 10.
PubMed 37951461
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods Used to Asses Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery
- ClinicalTrials.gov ID
- NCT06559566
- Acronym / sponsor ID
- BAGCILAR 3
- Conditions
- INTRACRANIAL TUMOR, INTRACRANIAL PRESSURE, OPTIC NERVE
- Keywords
- OPTIC NERVE, INTRACRANIAL PRESSURE, INTRACRANIAL TUMOR, INTRACRANIAL TUMOR SURGERY, Intracranial Pressure Change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sezen Kumaş SolakOther government
- Collaborators
- Bagcilar Training and Research Hospital
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 19 Aug 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.
Ultrasonography(USG)-guided optic nerve sheath diameter measurement and its correlation with brain computed tomography in the evaluation of intracranial pressure in patients who underwent intracranial brain tumor surgery.
Detailed description
Optic Nerve Sheath Diameter (ONSD) Measurement is a non-invasive diagnostic method used to detect increased intracranial pressure, and in general, ONSD measurement over 5 mm has been found to be associated with increased intracranial pressure.ONSD will be measured using an USG device within the specified time periods.
T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection
ONSD measurement in brain computer tomography (BCT); Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded.In patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5).
T0: ONSD measurement in pre-operative Brain CT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONSD measurement with USG | Active comparator | Procedure: USGAfter the ONSD measurement is made before anesthesia induction, general anesthesia will be given to each patient according to the institutional protocol. The ONSD measurements of the patients will be measured according to the T0, T1, T2, T3, T4, T5 time period by a person who has experience in using USG T0: Before anesthesia induction T1: First 5 minutes immediately after induction of anesthesia T2: At the end of the surgery before extubation /minute T3: Within the first hour/minute after extubation T4: 12 hours/minute after tumor resection T5. 24 hours/minute after tumor resection |
| ONSD measurement with BCT | Active comparator | Procedure: BCTIn patients, USG and BCT correlation comparison is planned before the operation (T0), in the first hour after the end of post-operative surgery (T3) and at the 24th hour after post-operative surgery (T5). T0: ONSD measurement in pre-operative BCT T3: BCT ONSD measurement/minute within the first hour following the postoperative period T5: BCT ONSD measurement/minute 24 hours following the postoperative period The measurement of ONSD in BCT is; Eyeball diameter and optic nerve diameter measurements will be made on BCT transverse images at the optic nerve level and recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 -65 years
- Brain malignant neoplasm tumor
- Brain benign neoplasm supratentorial
- Brain benign neoplasm infratentorial information
Key exclusion criteria (11 listed)
- Patients who cannot provide adequate image quality in ocular ultrasonography
- Who are unconscious or have a Glasgow coma scale of less than 15
- Pseudotumor cerebri
- Optic nerve arachnoid cyst
- Patients with open injuries involving the eyelid and surrounding area
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 |
|---|---|---|
| USGAlso: ONSD measurement with USGThe aim of this study is to measure the intracranial pressure of patients planned for brain tumor surgery by measuring the optic nerve sheath diameter (ONSD) under USG guidance and compare its correlation with the computed brain tomography. | Procedure or surgery | ONSD measurement with USG |
| BCTAlso: ONSD measurement with BCTThe aim of this study is to measure the intracranial pressure of patients planned for brain tumor surgery by measuring the optic nerve sheath diameter (ONSD) under USG guidance and compare its correlation with the computed brain tomography. | Procedure or surgery | ONSD measurement with BCT |
Primary outcome
intracranial pressure
Time frame: T0: Before anesthesia induction T1: peroperative5. minutes T2: At the end of the surgery 6.hours T3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
To compare the optic nerve diameter measurement ,USG and BBT values used to measure intracranial pressure in patients with brain tumor surgery
2 secondary outcomes
Heart Rate
Time frame: T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hoursT3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
Blood pressure
Time frame: T0: Before anesthesia induction T1: preoperative 5.minutes T2: At the end of the surgery 6.hours T3 extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Background: PubMed 34270144Stevens RRF, Gommer ED, Aries MJH, Ertl M, Mess WH, Huberts W, Delhaas T. Optic nerve sheath diameter assessment by neurosonology: A review of methodologic discrepancies. J Neuroimaging. 2021 Sep;31(5):814-825. doi: 10.1111/jon.12906. Epub 2021 Jul 16.
- Background: PubMed 27852525Raffiz M, Abdullah JM. Optic nerve sheath diameter measurement: a means of detecting raised ICP in adult traumatic and non-traumatic neurosurgical patients. Am J Emerg Med. 2017 Jan;35(1):150-153. doi: 10.1016/j.ajem.2016.09.044. Epub 2016 Sep 23.
- Background: PubMed 37951461Xu J, Song Y, Shah Nayaz BM, Shi W, Zhao Y, Liu Y, Wu S, Li Z, Sun Y, Zhao Y, Yu W, Wang X. Optic Nerve Sheath Diameter Sonography for the Diagnosis of Intracranial Hypertension in Traumatic Brain Injury: A Systematic Review and Meta-Analysis. World Neurosurg. 2024 Feb;182:136-143. doi: 10.1016/j.wneu.2023.11.016. Epub 2023 Nov 10.
- Individual participant dataSharing planned: No. The investigators will not share individual patient data
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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.
SEZEN KUMAS SOLAK, MD principal investigator
Bagcılar Training Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing USG and BCT in people with INTRACRANIAL TUMOR and INTRACRANIAL PRESSURE, run by Sezen Kumaş Solak.
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 4 inclusion and 11 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 SEZEN KUMAS SOLAK, MD (+905055729494, sezenkumassolak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial pressure (time frame: T0: Before anesthesia induction T1: peroperative5. minutes T2: At the end of the surgery 6.hours T3:after extubation 1 hours T4: postoperative 12.hours T5. postoperative 24.hours). 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 NCT06559566, 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 19 Aug 2024.