Actively Recruiting

Age: 18Years +
All Genders
NCT07443072

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery | DecenTrialz