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Incidence and severity of postoperative delirium associated with Dexmedetomidine sedation during femur osteosynthesis in the elderly population

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523070-16-00
Enrollment
80
Registered
2026-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-31

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

Conditions

Postoperative delirium

Brief summary

Prevalence, severity, and course of delirium during the postoperative period.

Detailed description

Clinical and epidemiological data, including factors associated with the onset of postoperative delirium., Sedative medications and administered doses, degree and quality of sedation as measured by the RASS scale (Appendix 1), events during sedation (episodes of agitation, need for restraint, etc.), and depth of sedation (BIS)., Clinical parameters (BP, SpO₂, HR, EtCO₂), basic laboratory tests (hemoglobin, electrolytes, blood glucose, and inflammatory markers such as CRP), and intra- and postoperative events (bleeding, blood product transfusion, hypertension/hypotension, desaturation, apnea, etc.)., Pain assessment (PA) and analgesia administered during the perioperative and postoperative periods.

Interventions

DRUGPropofol Lipuro 20 mg/ml emulsión inyectable y para perfusión

Sponsors

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Prevalence, severity, and course of delirium during the postoperative period.

Secondary

MeasureTime frame
Clinical and epidemiological data, including factors associated with the onset of postoperative delirium., Sedative medications and administered doses, degree and quality of sedation as measured by the RASS scale (Appendix 1), events during sedation (episodes of agitation, need for restraint, etc.), and depth of sedation (BIS)., Clinical parameters (BP, SpO₂, HR, EtCO₂), basic laboratory tests (hemoglobin, electrolytes, blood glucose, and inflammatory markers such as CRP), and intra- and postoperative events (bleeding, blood product transfusion, hypertension/hypotension, desaturation, apnea, etc.)., Pain assessment (PA) and analgesia administered during the perioperative and postoperative periods.

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 1, 2026