Clinical trial NCT06559566: Evaluation of Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery
Official title: Comparison of Two Methods Used to Asses Postoperative Intracranial Pressure in Patients Undergoing Intracranial Tumor Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: INTRACRANIAL TUMOR
INTRACRANIAL PRESSURE
OPTIC NERVE
Keywords: OPTIC NERVE
INTRACRANIAL PRESSURE
INTRACRANIAL TUMOR
INTRACRANIAL TUMOR SURGERY
Intracranial Pressure Change
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Bagcilar Training and Research Hospital
First posted: 2024-08-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility 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)

Primary outcomes:
measure: intracranial pressure
timeFrame: 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:
measure: Heart Rate
timeFrame: 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
measure: Blood pressure
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Bagcılar Training Research Hospital
name: SEZEN KUMAS SOLAK, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.