Alteration of Blood-Brain-Barrier Permeability at Loss of Consciousness in Delirious Patients Recorded With Direct-Current Electroencephalography (ACDC)

NCT04320082 | Terminated

• 1 other identifier: ACDC
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

With this trial we aim to characterize the intraoperative signatures of the Direct-Current-Electroencephalogram (DC-EEG) of elderly patients developing a PostOperative Delirium (POD) compared to patients who do not develop a POD. We hereby intend to gain a better understanding of the electrical potential at the blood-brain-barrier (measured with DC-EEG) during general anaesthesia. Second, we want to study the effect of age on the DC-EEG by comparing a younger (18-30y) to an elderly cohort (\>70). Third, we aim to couple the DC-EEG signatures to blood sample analysis in order to understand the relationship between metabolic, inflammatory and vascular reaction with the intraoperative DC-EEG.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 1. DC-Shift (µV/sec) in the perioperative DC-EEG.

  Full-brain DC-EEG with 21 electrodes placed preoperatively following the 10/20-System and recording until one hour after regain of consciousness.

  From the beginning of general anaesthesia to one hour after regain of consciousness

Secondary Outcomes (9)

• Incidence of Postoperative Delirium

  Patients will be follow until hospital discharge, or maximal until postoperative day 5

• Additional perioperative DC-EEG signatures: morphology, polarity (positive/negative), amplitude (µV)

  From the beginning of general anaesthesia to one hour after regain of consciousness

• DC-EEG signatures in young (18-30) vs. elderly (>70) patients

  From the beginning of general anaesthesia to one hour after regain of consciousness

• Analysis of pre-, intra- and postoperative blood parameters

  : From shortly before the beginning of general anaesthesia to maximum one hour after arrival in the recovery room

• Peri-operative, full-brain overall EEG band power

  Up to the end of stay in the recovery room

Study Arms (2)

Elderly cohort

Patients \>70 undergoing elective orthopaedic or trauma surgery under general anaesthesia.

Young cohort

Patients between 18 and 30 undergoing elective orthopaedic or trauma surgery under general anaesthesia.

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly Cohort: Patients \>70 undergoing elective orthopaedic or trauma surgery under general anaesthesia. Young cohort: Patients between 18 and 30 undergoing elective orthopaedic or trauma surgery under general anaesthesia.

You may qualify if:

• Patients aged \>70 years OR between 18 and 30
• Planned operation time \>1 hour
• Expected hospital treatment period of 5 days,
• Anesthesia induction, anesthesia maintenance with either Propofol or an inhalative anesthetic agent as Sevoflurane or Desflurane,
• The ability to give informed consent

You may not qualify if:

• Age under 18 or between 31 and 69
• Patients with a history of neurological or psychiatric disorders
• Planned neurosurgery
• Current medication of tranquilizers / antidepressants
• Isolation of patients with multi-resistant Bacteria
• Inability of the patients to speak and/or read German
• Intraoperative use of ketamine, N²O, Etomidate or Dexmedetomidine
• Participation in a prospective interventional trial

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Ansthesiology and Operative Intensive Care Medicine, Charité - Universitätsmedizin Berlin

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 24, 2020
• Study Start: August 10, 2020
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

DE (1)