Using dexmedetomidine to improve outcomes for elderly ICU patients after surgery

Impact of Low-dose Dexmedetomidine on Outcomes of Elderly Admitted to ICU After Noncardiac Surgery: a Randomized Controlled Trial

This study is testing if giving low doses of dexmedetomidine at night can help older patients in the ICU after surgery live longer and feel better over the next year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1410 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT04204798 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of low-dose dexmedetomidine on long-term outcomes in elderly patients admitted to the ICU following noncardiac surgery. The study builds on previous findings that showed dexmedetomidine can enhance sleep quality and reduce delirium in ICU patients. Participants will receive either dexmedetomidine or a placebo during nighttime hours, with the aim of assessing its impact on one-year survival rates and overall quality of life. The trial is randomized and controlled, ensuring a robust methodology for evaluating the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are elderly individuals aged 65 and older who are admitted to the ICU after noncardiac surgery and expected to stay overnight.

Not a fit: Patients with pre-existing neurological conditions or severe bradycardia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for elderly patients recovering from surgery in the ICU.

How similar studies have performed: Previous studies have shown promising results with dexmedetomidine in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥65 years old;
* Admitted to intensive care unit (ICU) after noncardiac surgery;
* Expected to stay in ICU until the next morning. For those with endotracheal intubation, the expected duration of mechanical ventilation is \<24 hours;
* Provide written informed consents.

Exclusion Criteria:

* Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
* Inability to communicate in the preoperative period (coma, profound dementia, or language barrier);
* Preoperative history of sleep apnea (previous diagnosis; or STOP-Bang score ≥3 with serum bicarbonate ≥ 28 mmol/L);
* Known sick sinus syndrome, severe sinus bradycardia (\<50 beats per min \[bpm\]), or second degree or higher atrioventricular block without pacemaker;
* Hypotension (systolic blood pressure \[SBP\] \<90 mmHg, mean arterial pressure \[MAP\] \<70 mmHg, or a decrease of SBP \>30% of baseline) or in a state of shock (vasopressors are required to maintain MAP ≥65 mmHg and serum lactate \>2 mmol/L);
* Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), or expected survival \<24 hours;
* Traumatic brain injury or neurosurgery;
* Presence of delirium before surgery (assessed with Confusion Assessment Method \[CAM\]/CAM-ICU);
* Undergoing treatment of dexmedetomidine or clonidine;
* Other conditions that are considered unsuitable for study participation.

Where this trial is running

Beijing, Beijing

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

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD

Conditions Elderly; Surgery; Intensive Care Unit; Dexmedetomidine; Overall Survival; Overall survival