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NIRS and BIS Monitoring During Cerebral Aneurysm Coiling

Evaluation of Near-Infrared Spectroscopy and Bispectral Index Monitoring During Cerebral Aneurysm Coil Embolization

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07438275
Acronym
NIRSBIS-ANEUR
Enrollment
75
Registered
2026-02-27
Start date
2026-03-01
Completion date
2026-10-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Aneurysm

Keywords

Near-Infrared Spectroscopy, Bispectral Index, Cerebral Oxygenation, Neuroanesthesia, Endovascular Treatment, Coil Embolization

Brief summary

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.

Detailed description

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.

Interventions

OTHERNear-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) Monitoring

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.

Sponsors

Dokuz Eylul University
Lead SponsorOTHER
Gaziantep City Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Patients scheduled for endovascular coil embolization for intracranial (cerebral) aneurysm * American Society of Anesthesiologists (ASA) physical status I-III * Undergoing the procedure under general anesthesia * Ability to provide written informed consent Criteria

Exclusion criteria

* Refusal or inability to provide informed consent * History of severe cerebrovascular disease other than the target aneurysm * Severe cardiac, pulmonary, hepatic, or renal dysfunction * Pre-existing neurological deficits interfering with NIRS or BIS interpretation * Known scalp or skin conditions preventing proper placement of NIRS or BIS sensors * Emergency procedures * Pregnancy -

Design outcomes

Primary

MeasureTime frameDescription
Correlation between intraoperative cerebral desaturation and intraoperative hemodynamic parametersDuring the intraoperative periodCorrelation 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: * Mean arterial pressure (mmHg), measured via invasive arterial catheter * Heart rate (beats per minute, bpm), measured using electrocardiography (ECG) * Peripheral oxygen saturation (SpO₂, %), measured via pulse oximetry * End-tidal carbon dioxide (EtCO₂, mmHg), measured using capnography * Bispectral Index (BIS, unitless scale 0-100), measured using a BIS monitor Correlation will be analyzed using Pearson or Spearman correlation coefficients, as appropriate.

Secondary

MeasureTime frameDescription
Correlation between Bispectral Index (BIS) values and regional cerebral oxygen saturation (rSO₂)From induction of anesthesia until completion of the endovascular procedureAssessment of the correlation between intraoperative BIS values and bilateral regional cerebral oxygen saturation (rSO₂) levels recorded at 5-minute intervals during the procedure.

Countries

Turkey (Türkiye)

Contacts

CONTACTGülay Akıncı, MD
dr.gulayakinci@gmail.com5053851909

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026