Actively Recruiting
Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-03-10
300
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients undergoing cranial neurosurgery face a high-risk postoperative period, particularly during emergence from anesthesia and early recovery in the post-anesthesia care unit (PACU). Standard monitoring provides limited insight into brain and autonomic recovery processes. Heart rate variability (HRV) and processed electroencephalography (pEEG) may offer complementary markers of autonomic and cortical function, with potential to improve early detection of complications and guide individualized care.
CONDITIONS
Official Title
Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (≥18 years) scheduled for elective cranial neurosurgery
- Planned extubation in the post-anesthesia care unit after surgery
- Ability to obtain high-quality ECG and EEG recordings intra- and postoperatively (≥60 minutes expected PACU monitoring)
- Written informed consent signed before surgery
You will not qualify if you...
- Pre-existing severe cardiac arrhythmias (e.g., atrial fibrillation, frequent ectopy) or pacemaker dependence
- Known severe autonomic neuropathy (e.g., advanced diabetes, Parkinson's disease with autonomic failure)
- Preoperative conditions with abnormal EEG (status epilepticus, uncontrolled seizures, sedative/hypnotic overdose)
- Intraoperative or immediate postoperative events requiring continued mechanical ventilation or ICU admission (e.g., massive bleeding, intraoperative arrest)
- Inability to provide informed consent (e.g., cognitive impairment, language barrier without interpreter)
- Refusal of informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Actively Recruiting
Research Team
A
Andrea Gentile, MD
CONTACT
M
Marco Gemma, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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