Prevention of Postoperative Delirium in Elderly Patients

NCT06248684 | Not Yet Recruiting

• 1 other identifier: Postoperative delirium project
• Study Type: interventional
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prevention of Postoperative Delirium in the care of Elderly Patients. A Monocentric, Prospective Intervention Study With the Question of Whether the Incidence, Length and Severity of Postoperative Delirium Can be Reduced by Implementing a Standardised, Multidimensional Delirium Management Protocol.

Conditions

Postoperative Delirium

Keywords

delirium, prevention and control; post operative delirium; delirium, risk factors; delirium, risk assessment; Baseline-EEG; cognitive tests; EEG, intraoperative

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Patients are examined once per shift for the described duration postoperatively using validated tests for delirium (CAM-ICU or 3D-CAM). Delirium testing is supplemented by pain assessment using the numerical rating scale (NRS).

  for three days postoperatively and if the patient is delirium positive on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest

Secondary Outcomes (8)

• duration of postoperative delirium

  for three days postoperatively and if the patient has delirium on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest

• Severity of the postoperative delirium

  for three days postoperatively and if the patient has delirium on the last day for the period until he is delirium negative or discharged from inpatient care, up to the day 90 visit at the latest

• Which parameters and tests detect patients at risk for postoperative delirium?

  From the time of premedication until three days postoperatively

• Can baseline and intraoperative EEG parameters be used to identify patients at risk? Does intraoperative burst suppression EEG represent a risk factor for delirium?

  From the patient's arrival in the operating room to three days postoperatively

• When is the diagnosis of postoperative delirium most commonly made?

  for three days postoperative

Study Arms (1)

prevention group

OTHER

patients receive standardized perioperative care using Standard Operating Procedures (SOPs) in accordance with the guidelines of the professional societies for the prevention of postoperative delirium.

Other: standardized prevention and therapy measures

Interventions

standardized prevention and therapy measures OTHER

Patients from the age of 65 years with an additional risk factor for postoperative delirium are assigned to a multidimensional standardized perioperative care protocol.

prevention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>= 65 Years
• intervention in one of the following departments: general and visceral surgery, urology, vascular surgery, orthopedics, trauma surgery,
• Written consent by patient or legal guardian

You may not qualify if:

• Foreign language patients without interpreter
• non-consenting patients without a legal representative

Sponsors & Collaborators

• Technical University of Munich: lead

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

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

• Gerhard Prof. Dr. med. Schneider, MD

  clinic for anesthesiology and intensive care, Klinikum rechts der Isar, Technical University Munich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Prof. Dr. med. Schneider, MD

CONTACT

+49-89-41404291; AINS@mri.tum.de

Stefanie PD Dr. med. Pilge, MD

CONTACT

+49-89-41404291; AINS@mri.tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2023
• First Posted: February 8, 2024
• Study Start: February 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share