Delirium - PostoperativeDEXLIRNCT07867899
Dexmedetomidine for Prevention of Delirium After Hip Fracture Surgery
An observational study of Delirium - Postoperative and Delirium Prevention, run by Peter Gaarsdal Uhrbrand at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium - Postoperative, Delirium Prevention, Dexmedetomidine
- Type of treatment
- Injection or infusion
- How many people
- 242 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2026to 14 Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Aarhus University Hospital
Aarhus, 8200
Peter G. Uhrbrand, MD, PhD, 004530615082, petuhr@rm.dk
About this study
Official title: Intraoperative Dexmedetomidine for Prevention of Postoperative Delirium in Patients Undergoing Hip Fracture Surgery: a Pre-post Study
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.
- Keywords
- Hip fracture, Surgery, Postoperative, Dexmedetomidine, Delirium prevention, Pre-post intervention, Geriatric anesthesia
- Medical subject headings
- Emergence Delirium, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation | Patients undergoing hip fracture surgery before implementation of intraoperative dexmedetomidine prophylaxis. | |
| Post-implementation / Dexmedetomidine prophylaxis | Patients 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postoperative day 1-3
Secondary outcomes (9)
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).
Measured: Postoperative day 1-7
Maximum severity of postoperative delirium
Maximum severity of postoperative delirium based on CAM score (mild, moderate, severe)
Measured: Postoperative day 1-7
Postoperative pain in the PACU
NRS (0-10) at rest and during mobilisation in the PACU
Measured: PACU stay
Postoperative opioid use in the PACU
Cumulative opioid consumption during the PACU stay (oral morphine milligram equivalents)
Measured: PACU stay
Need for antipsychotic medication
Any new use of haloperidol, olanzapine, risperidone, quetiapine or similar medication (yes/no)
Measured: Postoperative day 1-7
Intraoperative treatment with moderate-dose vasopressors
Intraoperative dose of norepinephrine > 0,1ug/kg/min (yes/no)
Measured: Intraoperative period
Perioperative treatment of bradycardia
Perioperative treatment of bradycardia with atropin (yes/no)
Measured: Intraoperative period and PACU stay
Postoperative vasopressor treatment
Any vasopressor use in the PACU (yes/no)
Measured: PACU stay
Length of stay in the PACU
Length of stay in the PACU (min)
Measured: PACU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Oct 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Gaarsdal Uhrbrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Gaarsdal Uhrbrand, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867899
- Sponsor's protocol ID
- 45026092
- Acronym
- DEXLIR
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The project is not approved for sharing individual participant data.