NCT07867899

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Oct 2026Apr 2027

First Submitted

Initial submission to the registry

September 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

6 months

First QC Date

September 23, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Hip fractureSurgeryPostoperativeDexmedetomidineDelirium preventionPre-post interventionGeriatric anesthesia

Outcome Measures

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).

    Postoperative day 1-3

Secondary Outcomes (9)

  • Any postoperative delirium within the first 7 days after surgery

    Postoperative day 1-7

  • Maximum severity of postoperative delirium

    Postoperative day 1-7

  • Postoperative pain in the PACU

    PACU stay

  • Postoperative opioid use in the PACU

    PACU stay

  • Need for antipsychotic medication

    Postoperative day 1-7

  • +4 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Emergence DeliriumHip Fractures

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Central Study Contacts

Peter G. Uhrbrand, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal and sponsor-investigator, MD, PhD

Study Record Dates

First Submitted

September 23, 2026

First Posted

October 9, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 14, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

The project is not approved for sharing individual participant data.

Locations