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Completed

NCT Number: NCT03879850

Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly

The investigators aim to identify preoperative Electroencephalogram (EEG) markers indicating patients at risk to develop postoperative delirium (POD), so that the anesthetist may adjust medications and dosages in order to avoid POD. Second, the investigators aim to specify intraoperative EEG signatures and EEG states that are related to POD and long-term cognitive dysfunction, again to enable physicians to adapt their procedure. Third, the investigators aim to identify EEG signatures during stay in the recovery room that is directly related to POD, and may therefore be used as diagnostic tool, as well as a predictor for the development of long-term cognitive deficits (POCD).

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Berlin, 13353, Germany

About this study

The investigators conduct this observational study to identify pre-, intra- and postoperative Electroencephalogram (EEG) signatures / intraoperative EEG states related to postoperative delirium (POD) and postoperative cognitive deficit (POCD) in elderly patients > 70 years. This includes the following tasks at five different time-points

  • Pre-operative frontal EEG recording during anesthesia evaluation one day before surgery / anesthesia to develop an EEG marker to predict the development of POD. This includes the stratification of EEG data related to age, gender, and pre-operative cognitive function. Pre-operative POCD assessment (CANTAB connect, word pair recognition test, Mini Mental State Test, and Trail Making Test A and B) to classify cognitive capacity of each patient before start of anesthesia.
  • Intra-operative frontal EEG recording from start of anesthesia procedure until discharge to the recovery room to identify EEG signatures / EEG states to predict the development of POD / POCD. This includes the stratification of EEG data related to age, gender, pre-medication, anesthetics, and analgesics used during anesthesia procedure.
  • Post-operative frontal EEG recording during the recovery room stay to develop an EEG marker / identify EEG signatures to diagnose POD and predict POCD. This includes the stratification of EEG data related to age, gender, anesthesia procedure, and analgesics administered during the recovery room stay. POD will be assessed during stay in the recovery room by the NuDesc Score and DSM V criteria.
  • Follow-up POD assessments until the 5th postoperative day, where the patient will be visited twice daily (8a.m.-10a.m. and 5p.m.-7p.m.) and assessed via DSM V / NuDesc criteria on the peripheral ward, or via Confusion Assessment Method for intensive Care Unit (CAM-ICU) criteria during an intensive care unit stay.
  • Follow-up POCD assessments one day before and 3 months after surgery, where the patient will undergo a ~1 hour cognitive testing with the CANTAB connect.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged >70 years
  • 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

Exclusion criteria

  • Patients with a history of neurological or psychiatric disorders
  • Known carotid artery Stenosis
  • Obstructive sleep apnea Syndrome
  • Planned neurosurgery
  • Current medication of tranquilizers / antidepressants
  • Isolation of patients with multi-resistant Bacteria
  • Inability of the patients to speak and/or read German
  • Homelessness or other circumstances where the patient would not be reachable by phone or postal services during follow-up
  • Intraoperative EEG data file analysis will be excluded ex post,
  • when intraoperative use of any other anesthetic agent for induction as Propofol occurred or
  • by use of any other anesthetic agent for anesthesia maintenance other than Propofol or volatile anesthetics as Sevoflurane or Desflurane or
  • when anesthesia agents as Ketamine, Nitrous oxide, Etomidate or Dexmedetomidine were given or
  • if body temperature drops below 34° or rises above 38° during surgery

Treatment and study plan

Primary outcomes

  1. Incidence of Postoperative Delirium- Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

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

    Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

  2. Incidence of Postoperative Delirium - Nursing Delrium Scale (Nu-DESC)

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

    Postoperative delirium rate, defined according to ≥ 2 cumulative points in the nursing Delirium Screening Scale (Nu-DESC)

  3. Incidence of Postoperative Delirium - Intensive Care Unit (CAM-ICU)

    Time frame: Patients will be followed on intensive care unit until hospital discharge, or maximal until postoperative day 5

    Postoperative delirium rate, defined according to positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) score

  4. Incidence of Postoperative Delirium - Confusion Assessment Method (CAM)

    Time frame: Patients will be followed on peripheral ward until hospital discharge, or maximal until postoperative day 5

    Postoperative delirium rate, defined according to positive Confusion Assessment Method (CAM)

Secondary outcomes

  1. Incidence of postoperative cognitive deficit (POCD) - CANTAB

    Time frame: Up to 3 months

    POCD will be measured by a defined Cambridge Neuropsychological Test Automated Battery (CANTAB) on the day before the operation and after 3 months

  2. Incidence of postoperative cognitive deficit (POCD) - MMSE

    Time frame: Up to 3 months

    POCD will be measured by Mini Mental State Examination (MMSE) on the day before the Operation, on day 5 and after 3 months

  3. Incidence of Neurocognitive disorder

    Time frame: Up to 3 months

    Neurocognitive Disorder is evaluated according to DSM-V (postoperative cognitive deficit, activities of daily living, instrumental activities of daily living, subjective memory sensing.

  4. Incidence of postoperative cognitive deficit (POCD) - Word pair recognition test

    Time frame: Up to 5 days

    POCD will be measured by Nürnberger-Altersinventar-Test - word pair recognition test on the day before the operation, day 1 ,3 and 5

  5. Post-operative, bi-frontal alpha-band power

    Time frame: Up to discharge from the recovery room

    Bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code

  6. Bi-frontal overall EEG band power

    Time frame: Up to discharge from the recovery room

    Postoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), Spectral analysis by Matlab code

  7. Burst suppression duration

    Time frame: During anesthesia procedure

    Intraoperative bi-frontal EEG recording with surface electrodes (Fp1, Fp2, F7 and F8), raw EEG analysis

  8. Pain monitoring

    Time frame: During anesthesia procedure

    Intraoperative pain monitoring is measured by Nociception Level Index (NOL

  9. Duration of Delirium (DSM-V)

    Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5

    Postoperative duration of delirium, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

  10. Duration of Delirium (Nu-DESC)

    Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5

    Postoperative duration of delirium, defined according to Nursing Delirium Screening Scale (Nu-DESC)

  11. Duration of Delirium (CAM-ICU)

    Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5

    Postoperative duration of delirium, defined according to Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)Confusion Assessment Method (CAM), Chart Review

  12. Duration of Delirium (CAM)

    Time frame: Participants will be followed for the duration of hospital stay, or maximal until postoperative day 5

    Postoperative duration of delirium, defined according to Confusion Assessment Method (CAM)

  13. Intensive care unit length of stay

    Time frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days

    Intensive care unit length of staywill be assessed by chart review at hospital discharge.

  14. Hospital length of stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    Hospital length of stay will be assessed by chart review at 3 months.

  15. Mortality

    Time frame: Up to 3 months

    Mortality will be assessed by chart review at 3 months.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Deutsche Forschung (Projekt No 409495393)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2019
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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