Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery
Recruiting now
Conditions studied: Cranial Neurosurgery
In brief
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.
Key facts
- Study ID
- NCT07443072
- Run by
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- People needed
- 300
- Starts
- 2026-03-05
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-03-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (≥18 years) scheduled for elective cranial neurosurgery.
- Planned extubation in the PACU after surgery.
- Ability to obtain high-quality ECG and EEG recordings intra- and postoperatively (≥60 min expected PACU monitoring).
- Written informed consent signed preoperatively.
You may not qualify if…
- 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 associated with abnormal EEG (status epilepticus, uncontrolled seizures, sedative/hypnotic overdose).
- Intraoperative or immediate postoperative events necessitating 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
Where it is running
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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