Using dexmedetomidine to reduce delirium after hip fracture surgery in elderly patients

Impact of Dexmedetomidine Supplemented Analgesia on Delirium and Long-term Outcomes in Elderly After Hip Fracture Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial

This study is testing if a medication called dexmedetomidine can help older patients have less confusion after hip fracture surgery and improve their recovery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1440 (estimated)
• Ages: 65 Years to 89 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT04955249 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of dexmedetomidine supplemented analgesia on elderly patients undergoing hip fracture surgery. The study aims to determine if this approach can reduce the incidence of postoperative delirium and improve long-term outcomes. By utilizing patient-controlled intravenous analgesia, the trial will assess the sedative and analgesic properties of dexmedetomidine, which may alleviate pain and inflammation associated with surgery. The hypothesis is based on previous findings that suggest dexmedetomidine can enhance sleep quality and reduce delirium in similar patient populations.

Who should consider this trial

Good fit: Ideal candidates are elderly individuals aged 65 to 89 who are scheduled for hip fracture surgery and plan to use patient-controlled analgesia postoperatively.

Not a fit: Patients with severe preoperative conditions such as schizophrenia, severe dementia, or significant cardiac and respiratory issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the occurrence of delirium and improve recovery outcomes for elderly patients after hip fracture surgery.

How similar studies have performed: Previous studies have shown that dexmedetomidine can improve outcomes in elderly patients after non-cardiac surgery, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 65 years but \< 90 years;
* Scheduled to undergo hip fracture surgery;
* Planned to use patient-controlled intravenous analgesia (PCIA) after surgery.

Exclusion Criteria:

* Refuse to participate in this study;
* Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
* Inability to communicate in the preoperative period because of coma, profound dementia or language barrier;
* Preoperative obstructive sleep apnea (diagnosed sleep apnea syndrome or a STOP-Bang score ≥3 combined with a serum bicarbonate ≥28 mmol/L);
* Sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker;
* Severe hepatic dysfunction (Child-Pugh class C);
* Severe renal dysfunction (requirement of renal replacement therapy before surgery);
* American Society of Anesthesiologists physical status \>IV, or estimated survival ≤24 h.

Where this trial is running

Beijing

• Peking University First Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Study Principal Investigator
• Study coordinator: Dong-Xin Wang

Conditions Elderly; Hip Fracture Surgery; Patient-controlled Analgesia; Dexmedetomidine; Postoperative Delirium; Hip fracture surgery; Patient-controlled analgesia; Postoperative delirium