Spinal morphine in patients with hip fractures to reduce delirium

Recruiting

• Conditions: Proximal femur fracture, delirium

• Registration Number: NL-OMON27635
• Lead Sponsor: Maasstad Hospital Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 364

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Femur fracture
- Scheduled for surgery
- Spinal anesthesia

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contraindications for spinal anesthesia:
o Patients’ refusal
o Coagulation disorders (clopidogrel, INR>1.8, anticoagulation with nadroparine (>100 aXa-IE/kg), 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).
o Aortic Valve Stenosis of AVA < 1.0 cm2
o Lumbar malformations (local inflammation, lumbar osteosynthesis material, meningocele, tethered cord)
- Inability to retrieve cerebrospinal fluid by lumbar puncture.
- Contra-indications for intrathecal morphine:
o Chronic opioid or benzodiazepine use (>1 month daily use).
- Allergies to amide-type local anesthetics and morphine.
- Patients who are incapable of making decisions regarding anesthesia and no legal representative is available.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium during hospital admission, defined according to the DSM-5 criteria