Using dexmedetomidine to improve outcomes for elderly ICU patients after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: wangdongxin@hotmail.com
• Phone: (86)10-83572784

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.