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Spinal morphine in patients with hip fractures to reduce delirium

Spinal morphine in patients with hip fractures to reduce delirium - SALMON-mind

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54044
Enrollment
364
Registered
2021-01-26
Start date
2022-03-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

delirium hip fracture

Interventions

The addition of 100 mcg morphine to the intrathecal injection for spinal anesthesia.

Sponsors

Maasstadziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Proximal femur fracture Scheduled for surgerical treatment Spinal anesthesia

Exclusion criteria

Exclusion criteria: Contraindications for spinal anesthesia: - Coagulation disorders (clopidogrel, INR>1.8, anticoagulation with nadroparine (>100 aXa-IE/kg) or heparine (APTT> 30 sec), recent use of a Direct Oral Anticoagulant, as stated in the guideline *Neuraxisblokkade en antistolling* by the Dutch Society of Anesthesiology. - Aortic Valve Stenosis of AVA 1 month daily use). Other: - Allergies to amide-type local anesthetics and morphine. - Patients* refusal - Patients who are incapable of making decisions regarding anesthesia and no legal representative is available.

Design outcomes

Primary

MeasureTime frame
The incidence of delirium during hospital admission

Secondary

MeasureTime frame
Secondary outcomes are o Delirium Observation Screening Scale (DOSS)-scores (three times daily), o pain scores on a Numeric Rating Scale (NRS), o post-operative opioid consumption, o post-operative consumption of ondansetron for nausea or pruritus, o Patient questionnaire with the Quality of Recovery-15 on POD 1 (including subscales), o Pruritus-severity score on POD 1, o time of mobilization after surgery, o occurrence of complications such as infections, cerebrovascular disorders, respiratory insufficiency and myocardial injury, o mortality, o discharge facility, o length of hospital stay. Tertiary outcome is the serum level of NFL on the second post-operative day.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)