NIRS and BIS Monitoring During Cerebral Aneurysm Coiling (NIRSBIS-ANEUR)

February 22, 2026 updated by: Gülay Akıncı, Dokuz Eylul University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

  • 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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between intraoperative cerebral desaturation and intraoperative hemodynamic parameters
Time Frame: During the intraoperative period

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Bispectral Index (BIS) values and regional cerebral oxygen saturation (rSO₂)
Time Frame: From induction of anesthesia until completion of the endovascular procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Collaborators

Gaziantep City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 22, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSH-NIRS-BIS-ANEUR-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available in order to protect participant confidentiality and in accordance with institutional regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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