Gülay Akıncı
Gaziantep, Turkey (Türkiye)
Location contact
Gülay Akıncı
CONTACT
Gülay Akıncı, MD
CONTACT
Gülay Akıncı, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07438275
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Gaziantep, Turkey (Türkiye)
Gülay Akıncı
CONTACT
Gülay Akıncı, MD
CONTACT
Gülay Akıncı, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
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.
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:
Correlation will be analyzed using Pearson or Spearman correlation coefficients, as appropriate.
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.
Contact information is provided by the study sponsor or research team.
Dokuz Eylul University
Other
Evaluation of Near-Infrared Spectroscopy and Bispectral Index Monitoring During Cerebral Aneurysm Coil Embolization
Acronym: NIRSBIS-ANEUR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06600997
Aneurysm, Brain Diseases
View Trial DetailsNCT05776706
Aneurysm, Arteriovenous Malformations
Seoul, South Korea
View Trial DetailsNCT05774782
Aneurysm, Brain Diseases
Beijing, China
View Trial DetailsNCT05945563
Aneurysm, Brain Diseases
Dallas, Texas, United States
View Trial Details