Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery

NCT ID: NCT06559566

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-05-01

Brief Summary

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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

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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

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INTRACRANIAL TUMOR INTRACRANIAL PRESSURE OPTIC NERVE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

USG

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

BCT

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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ONSD measurement with USG ONSD measurement with BCT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Sezen Kumaş Solak

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sezen Kumaş Solak

SPONSOR INVESTIGATOR

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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SEZEN KUMAS SOLAK, MD

Role: PRINCIPAL_INVESTIGATOR

Bagcılar Training Research Hospital

Central Contacts

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SEZEN KUMAS SOLAK, MD

Role: CONTACT

+905055729494

References

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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.

Reference Type BACKGROUND
PMID: 34270144 (View on PubMed)

Raffiz 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.

Reference Type BACKGROUND
PMID: 27852525 (View on PubMed)

Xu 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.

Reference Type BACKGROUND
PMID: 37951461 (View on PubMed)

Other Identifiers

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BAGCILAR 3

Identifier Type: -

Identifier Source: org_study_id

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