Health TrialsbyHealthPanel

Dexmedetomidine for Prevention of Delirium After Hip Fracture Surgery

ConditionsDelirium - PostoperativeDelirium PreventionDexmedetomidineDexmedetomidine Infusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorPeter Gaarsdal Uhrbrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Study participants will be selected from patients undergoing surgery for hip fracture at the Department of Orthopedics, Aarhus University Hospital, Denmark. The study population will include patients aged 65 years or older undergoing operative treatment in either general or spinal anesthesia. Patients will be identified consecutively during the predefined pre-implementation and post-implementation study periods. In the post-implementation period, eligible patients will receive perioperative dexmedetomidine prophylaxis unless contraindications or other clinical reasons for omission are present. Patients with severe liver failure, acute neurological conditions, or second- or third-degree atrioventricular block without a pacemaker will not receive dexmedetomidine

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

242 Participants
are grouped into 2 trial groups
Group A: Pre-implementation
Group B: Post-implementation / Dexmedetomidine prophylaxis

Trial outcomes

Primary outcomes

1

Any postoperative delirium within the first 3 days after surgery

The proportion of patients with at least one positive CAM-score on postoperative day 1-3 (yes/no).

Time frame
Postoperative day 1-3

Secondary outcomes

1

Any postoperative delirium within the first 7 days after surgery

The proportion of patients with at least one positive CAM-score on postoperative day 1-7 (yes/no).

Time frame
Postoperative day 1-7
2

Maximum severity of postoperative delirium

Maximum severity of postoperative delirium based on CAM score (mild, moderate, severe)

Time frame
Postoperative day 1-7
3

Postoperative pain in the PACU

NRS (0-10) at rest and during mobilisation in the PACU

Time frame
PACU stay
4

Postoperative opioid use in the PACU

Cumulative opioid consumption during the PACU stay (oral morphine milligram equivalents)

Time frame
PACU stay

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter Gaarsdal Uhrbrand

Lead sponsor

Aarhus University Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now