Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery

NCT06559566 | Not Yet Recruiting

• 1 other identifier: BAGCILAR 3
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

INTRACRANIAL TUMOR; INTRACRANIAL PRESSURE; OPTIC NERVE

Keywords

OPTIC NERVE; INTRACRANIAL PRESSURE; INTRACRANIAL TUMOR; INTRACRANIAL TUMOR SURGERY; Intracranial Pressure Change

Outcome Measures

Primary Outcomes (1)

• intracranial pressure

  To compare the optic nerve diameter measurement ,USG and BBT values used to measure intracranial pressure in patients with brain tumor surgery

  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

  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

  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

Study Arms (2)

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

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.

Procedure: BCT

Interventions

USG 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.

Also known as: ONSD measurement with USG

ONSD measurement with USG

BCT 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.

Also known as: ONSD measurement with BCT

ONSD measurement with BCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 -65 years
• Brain malignant neoplasm tumor
• Brain benign neoplasm supratentorial
• Brain benign neoplasm infratentorial information

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sezen Kumaş Solak: lead
• Bagcilar Training and Research Hospital: collaborator

Related Publications (3)

• 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.

  PMID: 34270144 BACKGROUND

• 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.

  PMID: 27852525 BACKGROUND

• 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.

  PMID: 37951461 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• SEZEN KUMAS SOLAK, MD

  Bagcılar Training Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEZEN KUMAS SOLAK, MD

CONTACT

+905055729494; sezenkumassolak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: SPONSOR INVESTIGATOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 19, 2024
• Study Start: September 15, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share