Dexmedetomidine for Prevention of Delirium After Hip Fracture Surgery

NCT07867899 — Recruiting, 242 participants, Peter Gaarsdal Uhrbrand

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Intraoperative Dexmedetomidine for Prevention of Postoperative Delirium in Patients Undergoing Hip Fracture Surgery: a Pre-post Study

RegistryNCT07867899, acronym DEXLIR
StatusRecruiting
Study typeObservational
Enrollment242 (Estimated)
SponsorPeter Gaarsdal Uhrbrand (Other)
ConditionsDelirium - Postoperative, Delirium Prevention, Dexmedetomidine, Dexmedetomidine Infusion
Datesstart 2026-10-01, primary completion 2027-03-31 (estimated), completion 2027-04-14 (estimated), first posted 2026-10-09, last updated 2026-10-09
Locations1 site in Denmark

Related Papers Related Patents Related Grants Related Experts
All trials for Delirium - Postoperative All trials for Delirium Prevention

-Summary

Postoperative delirium is common after hip fracture surgery and is associated with delayed recovery and serious postoperative complications. Patients with hip fracture are often elderly, acutely admitted, in pain, and have multiple comorbidities, all of which increase the risk of delirium.

This study evaluates whether implementation of intraoperative dexmedetomidine prophylaxis reduces postoperative delirium in patients undergoing hip fracture surgery. The study will compare patients treated before and after implementation of dexmedetomidine prophylaxis.

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+Arms and interventions

ArmTypeInterventionsDescription
Pre-implementationPatients undergoing hip fracture surgery before implementation of intraoperative dexmedetomidine prophylaxis.
Post-implementation / Dexmedetomidine prophylaxisPatients undergoing hip fracture surgery after implementation of intraoperative dexmedetomidine prophylaxis. Dexmedetomidine prophylaxis is initiated after induction of general anesthesia or after spinal anesthesia has been established. Patients receive dexmedetomidine bolus 0.5 µg/kg ideal body weight followed by infusion 0.5 µg/kg/hour. The infusion is discontinued at the end of surgery.

+Outcome measures

Primary outcomes

  • Any postoperative delirium within the first 3 days after surgery [Postoperative day 1-3]: The proportion of patients with at least one positive CAM-score on postoperative day 1-3 (yes/no).

Secondary outcomes

  • Any postoperative delirium within the first 7 days after surgery [Postoperative day 1-7]: The proportion of patients with at least one positive CAM-score on postoperative day 1-7 (yes/no).
  • Maximum severity of postoperative delirium [Postoperative day 1-7]: Maximum severity of postoperative delirium based on CAM score (mild, moderate, severe)
  • Postoperative pain in the PACU [PACU stay]: NRS (0-10) at rest and during mobilisation in the PACU
  • Postoperative opioid use in the PACU [PACU stay]: Cumulative opioid consumption during the PACU stay (oral morphine milligram equivalents)
  • Need for antipsychotic medication [Postoperative day 1-7]: Any new use of haloperidol, olanzapine, risperidone, quetiapine or similar medication (yes/no)
  • Intraoperative treatment with moderate-dose vasopressors [Intraoperative period]: Intraoperative dose of norepinephrine > 0,1ug/kg/min (yes/no)
  • Perioperative treatment of bradycardia [Intraoperative period and PACU stay]: Perioperative treatment of bradycardia with atropin (yes/no)
  • Postoperative vasopressor treatment [PACU stay]: Any vasopressor use in the PACU (yes/no)
  • Length of stay in the PACU [PACU stay]: Length of stay in the PACU (min)

+Eligibility

Sex: All, ages: 65 Years to any

Inclusion Criteria:

* Patients at least 65 years of age undergoing surgery for hip fracture in general or spinal anesthesia
* Treated during the defined pre- or post-implementation period

Exclusion Criteria:

* Known hypersensitivity to dexmedetomidine
* Second- or third-degree AV block without pacemaker
* Acute cerebral conditions with potentially impaired cerebral autoregulation
* Acute or chronic liver failure

+Locations (1)

FacilityCityCountryStatus
Department of Anesthesiology, Aarhus University HospitalAarhusDenmarkRecruiting