Perioperative Electroencephalography Characteristics of Postoperative Delirium in Elderly

NCT03879850 | Completed

• 1 other identifier: EPOD
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (4)

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

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

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

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

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

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

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

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

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

• Incidence of Postoperative Delirium - Confusion Assessment Method (CAM)

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

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

Secondary Outcomes (15)

• Incidence of postoperative cognitive deficit (POCD) - CANTAB

  Up to 3 months

• Incidence of postoperative cognitive deficit (POCD) - MMSE

  Up to 3 months

• Incidence of Neurocognitive disorder

  Up to 3 months

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

  Up to 5 days

• Post-operative, bi-frontal alpha-band power

  Up to discharge from the recovery room

Study Arms (2)

Propofol group

This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - i.v. Propofol - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients.

Volatile group

This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - volatile anesthetic agent as Sevoflurane or Desflurane - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective, observational study in surgical patients undergoing elective surgery under general anesthesia stratified for the anesthetic agent used intraoperatively - i.v. Propofol (Propofol group) or volatile anesthetic agent as Sevoflurane or Desflurane (Volatile group) - focusing on pre-, intra- and postoperative EEG spectral parameters in elderly patients.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Deutsche Forschung (Projekt No 409495393): collaborator

Study Sites (1)

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

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 Anesthesiology and Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 19, 2019
• Study Start: March 19, 2019
• Primary Completion: November 24, 2022
• Study Completion: November 28, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)