NIRS and BIS Monitoring During Cerebral Aneurysm Coiling

NCT07438275 | Not Yet Recruiting

• 1 other identifier: GSH-NIRS-BIS-ANEUR-2025
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Aneurysm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  During the intraoperative period

Secondary Outcomes (1)

• Correlation between Bispectral Index (BIS) values and regional cerebral oxygen saturation (rSO₂)

  From induction of anesthesia until completion of the endovascular procedure

Study Arms (1)

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.

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

Interventions

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.

Cerebral Aneurysm Patients Undergoing Coil Embolization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Gaziantep City Hospital: collaborator

Study Sites (1)

Gülay Akıncı

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Gülay Akıncı, MD

CONTACT

5053851909; dr.gulayakinci@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)