NIRS and BIS Monitoring During Cerebral Aneurysm Coiling

ConditionCerebral Aneurysm

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorDokuz Eylul University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) Monitoring
Other intervention
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.

Treatment groups

75 Participants

are divided into 1 treatment group

Group A: Cerebral Aneurysm Patients Undergoing Coil Embolization1 intervention

Trial outcomes

Primary outcomes

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: * 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.

Time frame

During the intraoperative period

Secondary outcomes

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.

Time frame

From induction of anesthesia until completion of the endovascular procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dokuz Eylul University

Lead sponsor

Gaziantep City Hospital

Collaborator

Source ClinicalTrials.gov

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