NCT07443072 Heart Rate Variability and Processed EEG Features as Predictors of Postoperative Outcomes After Cranial Neurosurgery
| NCT ID | NCT07443072 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Cranial Neurosurgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-03-05 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-03-05 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07443072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cranial Neurosurgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07443072 currently recruiting?
Yes, NCT07443072 is actively recruiting participants. Contact the research team at andrea.gentile@istituto-besta.it for enrollment information.
Where is the NCT07443072 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07443072 clinical trial?
NCT07443072 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 300 participants.