Electroencephalogram Predicts Post-operative Delirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Sanbo Brain Hospital
About this trial
The goal of this observational study is to investigate the predictive value of sub-hairline electroencephalography (EEG) during anesthesia recovery for postoperative delirium (POD). The main question to be answered is:
* Can sub-hairline EEG measured during anesthesia recovery serve as a reliable predictor of POD? Adult patients undergoing elective craniotomy and admitted to the ICU will be enrolled. Sub-hairline EEG will be monitored until ICU discharge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Planned elective neurosurgical surgery
ASA physical status I-II
Signed informed consent
Disqualifiers
Known neurological or psychiatric disorders (e.g., epilepsy, Parkinson's disease)
Preoperative cognitive impairment (MMSE score < 24)
Long-term use of central nervous system drugs (e.g., antidepressants, antipsychotics)
Language barriers
Trial population
The study will recruit participants from patients scheduled for elective neurosurgical procedures at Sanbo Brain Hospital, Capital Medical Universtiy in Beijing, China. The population will consist of adult patients aged ≥18 years who are classified as ASA physical status I-II, indicating generally healthy individuals or those with mild systemic disease. Participants will be identified through pre-surgical assessments and referred by their attending neurosurgeons for enrollment in the study. This cohort will be selected from those undergoing elective craniotomy. Eligible participants will be consented prior to surgery, and sub-hairline EEG monitoring will be initiated during the early anesthesia recovery phase in the ICU.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sub-hairline EEG Monitoring
Diagnostic testParticipants will receive standard postoperative care as per institutional protocols, including neuromonitoring, delirium screening, and ICU management. The study will not alter or assign any treatments but will analyze the association between sub-hairline EEG parameters and postoperative delirium (POD) outcomes
Treatment groups
137 Participants
are divided into 2 treatment groupsGroup A: POD group1 intervention
Group B: Non-POD group1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Postoperative Delirium (POD)
The primary outcome of this study is to assess whether sub-hairline EEG parameters recorded during anesthesia recovery can reliably predict the incidence of postoperative delirium (POD) within the first 7 days following elective craniotomy.
Time frame
Within 7 days post-surgerySecondary outcomes
1
Spectral power of Sub-Hairline EEG theta wave
To evaluate whether changes in sub-hairline EEG parameters (e.g., spectral power, burst suppression ratio, and connectivity metrics) during the early postoperative period are associated with the onset and severity of POD.
Time frame
Within 7 days post-surgery2
Hospital Length of Stay
To investigate if the use of sub-hairline EEG during anesthesia recovery correlates with the length of ICU and total hospital stay.
Time frame
through study completion, an average of 30 days3
Incidence of Postoperative Complications (PPCs)
To evaluate the incidence of postoperative complications, including pneumonia, atelectasis, brain ischemia, edema, and haemorrhage, and whether these are correlated with sub-hairline EEG parameters.
Time frame
through study completion, an average of 1 week4
Analysis of EEG Patterns and Delirium Onset
To explore any correlation between specific sub-hairline EEG patterns (e.g., burst suppression ratio, alpha or theta waves) and the early onset of delirium.
Time frame
through study completion, an average of 1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Sanbo Brain Hospital
Lead sponsor
Capital Medical University
Sponsor institution
Source ClinicalTrials.gov