POSitive auditory SUggestions during general anaesthesia reduce DELirium and improve vegetative and cognitive outcome: A multi-centre double blind randomized interventional trial

Not Applicable

• Conditions: F05.0; R11; R52.0; Delirium not superimposed on dementia, so described; Nausea and vomiting; Acute pain

• Registration Number: DRKS00030589
• Lead Sponsor: MU Klinikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Patients undergoing hip or knee surgery lasting 1-3 hours under general anesthesia using total intravenous anesthesia (TIVA) according to local standards
Age 60 years or older
German as mother tongue
sufficiently good hearing
Eligibility for consent

Exclusion Criteria

Patients with hearing loss
Delirium at hospital admission
Language barrier
Rejection by patients
haemoglobin >10 g/dl

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Delirium day 1-5 (DSM-V, 3DCAM, 4AT, CAM-ICU)

Secondary Outcome Measures

Name	Time	Method
intraoperative nociception level (NOL) <br>PACU (1-2h), ward (16-32h): Pain intensity (NAS), painkiller consumption (morphine equivalent), Occurrence of PONV, PONV intensity (Wengritzky score) <br>Neurocognitive function (RBANS) after 6 months <br>Influence of speaker gender <br>Biomarkers of neurocognitive function (preoperative, 16-32 h postoperatively, 3-6 months)