Cerebral AneurysmNIRSBIS-ANEURNCT07438275
NIRS and BIS Monitoring During Cerebral Aneurysm Coiling
An observational study of Cerebral Aneurysm, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) Monitoring
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gülay Akıncı
Gaziantep
Gülay Akıncı, MD, 5053851909, dr.gulayakinci@gmail.com
Gülay Akıncı, dr.gulayakinci@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Aneurysm
- Being tested
- Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) Monitoring
- Keywords
- Near-Infrared Spectroscopy, Bispectral Index, Cerebral Oxygenation, Neuroanesthesia, Endovascular Treatment, Coil Embolization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the intraoperative period
Secondary outcomes (1)
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.
Measured: From induction of anesthesia until completion of the endovascular procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026
- Primary completion1 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Gaziantep City Hospital
- Responsible party
- Principal investigator, Gülay Akıncı, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438275
- Sponsor's protocol ID
- GSH-NIRS-BIS-ANEUR-2025
- Acronym
- NIRSBIS-ANEUR
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available in order to protect participant confidentiality and in accordance with institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Near-Infrared Spectroscopy and Bispectral Index Monitoring During Cerebral Aneurysm Coil Embolization
- ClinicalTrials.gov ID
- NCT07438275
- Acronym / sponsor ID
- NIRSBIS-ANEUR / GSH-NIRS-BIS-ANEUR-2025
- Conditions
- Cerebral Aneurysm
- Keywords
- Near-Infrared Spectroscopy, Bispectral Index, Cerebral Oxygenation, Neuroanesthesia, Endovascular Treatment, Coil Embolization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Gaziantep City Hospital
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Aneurysm Patients Undergoing Coil Embolization | – | Other: Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) MonitoringAdult 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-Infrared Spectroscopy (NIRS) and Bispectral Index (BIS) MonitoringNear-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. | Other | Cerebral Aneurysm Patients Undergoing Coil Embolization |
Primary outcome
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.
1 secondary outcome
Correlation between Bispectral Index (BIS) values and regional cerebral oxygen saturation (rSO₂)
Time frame: From induction of anesthesia until completion of the endovascular procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Aneurysm, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gülay Akıncı, MD (5053851909, dr.gulayakinci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between intraoperative cerebral desaturation and intraoperative hemodynamic parameters (time frame: During the intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.