Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients over 18 -65 years.

- Brain malignant neoplasm tumor.

- Brain benign neoplasm supratentorial.

- Brain benign neoplasm infratentorial information.

Exclusion Criteria:

- 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.

- Injury of the optic nerve and its pathways.

- Systemic Lupus Erythematosis, - Scleroderma.

- Multiple Sclerosis, sarcoidosis.

- Thyrotoxicosis (hyperthyroidism)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06559566
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sezen Kumaş Solak
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	SEZEN KUMAS SOLAK, MD
Principal Investigator Affiliation	Bagcılar Training Research Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	INTRACRANIAL TUMOR, INTRACRANIAL PRESSURE, OPTIC NERVE

Additional Details

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

Arms & Interventions

Arms

Active Comparator: ONSD measurement with USG

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

Active Comparator: ONSD measurement with BCT

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.

Interventions

Procedure: - 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.

Procedure: - BCT

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

SEZEN KUMAS SOLAK, MD

[email protected]

+905055729494

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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