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| Name | Class |
|---|---|
| Gaziantep City Hospital | OTHER |
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This prospective observational study aims to evaluate the effectiveness of Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) monitoring during endovascular coil embolization of cerebral aneurysms under general anesthesia. Changes in regional cerebral oxygen saturation (rSO₂) measured by NIRS will be assessed in relation to BIS values and hemodynamic parameters throughout the procedure.
The frequency, duration, and severity of cerebral desaturation episodes detected by NIRS, as well as their association with anesthetic depth and hemodynamic fluctuations, will be analyzed. The study does not involve any additional intervention beyond routine clinical monitoring.
Cerebral aneurysm coil embolization carries a potential risk of cerebral hypoperfusion and ischemia during the intraoperative period. Near-Infrared Spectroscopy (NIRS) provides continuous, non-invasive monitoring of regional cerebral oxygen saturation, while Bispectral Index (BIS) allows assessment of anesthetic depth.
In this prospective observational study, adult patients undergoing endovascular coil embolization for cerebral aneurysms under general anesthesia will be monitored using standard anesthesia monitoring, including NIRS and BIS, which are part of routine clinical practice at the study center.
Baseline NIRS and BIS values will be recorded prior to anesthetic induction, followed by continuous intraoperative monitoring at predefined time points. A decrease of ≥20% from baseline rSO₂ will be defined as clinically significant cerebral desaturation. Relationships between NIRS values, BIS measurements, and hemodynamic parameters will be evaluated.
The study aims to contribute to the understanding of multimodal neuromonitoring during neuroendovascular procedures and to support clinical decision-making regarding cerebral protection strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral Aneurysm Patients Undergoing Coil Embolization | Adult patients undergoing endovascular coil embolization for cerebral aneurysm under general anesthesia. Near-infrared spectroscopy (NIRS) and bispectral index (BIS) monitoring are performed as part of routine clinical anesthesia care, and intraoperative neuromonitoring and hemodynamic data are recorded observationally without any additional intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) Monitoring | Other | Near-infrared spectroscopy (NIRS) and bispectral index (BIS) monitoring are performed as part of routine intraoperative anesthesia monitoring during endovascular coil embolization for cerebral aneurysm. No additional intervention beyond standard clinical care is applied; data are recorded observationally. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between intraoperative cerebral desaturation and intraoperative hemodynamic parameters | Correlation between intraoperative cerebral desaturation episodes (defined as a ≥20% decrease from baseline regional cerebral oxygen saturation [rSO₂], measured as percentage (%) using Near-Infrared Spectroscopy [NIRS]) and the following intraoperative parameters:
Correlation will be analyzed using Pearson or Spearman correlation coefficients, as appropriate. | During the intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Bispectral Index (BIS) values and regional cerebral oxygen saturation (rSO₂) | Assessment of the correlation between intraoperative BIS values and bilateral regional cerebral oxygen saturation (rSO₂) levels recorded at 5-minute intervals during the procedure. | From induction of anesthesia until completion of the endovascular procedure |
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Exclusion Criteria:
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Adult patients diagnosed with intracranial (cerebral) aneurysm who are scheduled to undergo endovascular coil embolization under general anesthesia. Participants will be monitored intraoperatively using near-infrared spectroscopy (NIRS) and bispectral index (BIS) as part of standard anesthetic care. The study population represents a real-world cohort of patients undergoing elective neurointerventional procedures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gülay Akıncı, MD | Contact | 5053851909 | dr.gulayakinci@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gülay Akıncı | Gaziantep | Turkey (Türkiye) |
Individual participant data will not be made publicly available in order to protect participant confidentiality and in accordance with institutional regulations.
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |