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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030589
Enrollment
280
Registered
2022-10-25
Start date
2022-11-09
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F05.0 R11 R52.0

Interventions

Group 1: positive suggestion intervention via headphones (different gender speaker) Group 2: positive suggestion intervention via headphones (same gender speaker) Group 3: control (headphones without

Sponsors

LMU Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Postoperative Delirium day 1-5 (DSM-V, 3DCAM, 4AT, CAM-ICU)

Secondary

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

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026