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Active, not recruitingNCT04204798Updated Jul 31, 2025

Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery

An interventional study of Dexmedetomidine and Placebo in Elderly, Surgery and Intensive Care Unit, sponsored by Peking University First Hospital. Active, not recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,410
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

Sleep disorder and delirium are common problems in intensive care unit (ICU) patients, and may lead to poor prognosis. The investigators' previous study showed that nighttime infusion of low-dose dexmedetomidine improved the sleep quality and decreased the incidence of delirium in ICU patients after surgery. Long-term follow-up of these patients showed that low-dose dexmedetomidine also improved 2-year survival and the quality of life in 3-year survivors. The purpose of this study is to investigate the effect of low-dose dexmedetomidine on the long-term outcome of elderly patients admitted to the ICU after noncardiac surgery.

Read the detailed description

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic and anti-anxiety properties. Unlike other sedative agents, dexmedetomidine exerts its sedative effects through an endogenous sleep-promoting pathway, producing a state like non-rapid eye movement sleep. For mechanically ventilated patients, sedative-dose dexmedetomidine infusion at night maintains circadian rhythm, increases sleep efficiency, and improves sleep architecture. When used for sedation in mechanical ventilated patients, it reduces the incidence of delirium.

Dexmedetomidine may improve patient outcomes by improving sleep quality. A previous randomized trial found that, for elderly patients who were admitted to ICU after noncardiac surgery, nighttime infusion of low-dose dexmedetomidine significantly improves the sleep quality and decreases the incidence of postoperative delirium. A long-term follow-up of these patients showed that low-dose dexmedetomidine infusion significantly increased survival up to 2 years, and improved cognitive function and quality of life in 3-year survivors.

In the study mentioned above, dexmedetomidine was only infused during the night after surgery with a fixed dose. The investigators hypothesize that, for elderly admitted to ICU after surgery, nighttime infusion of individualized low-dose dexmedetomidine may improve long-term outcomes. This randomized controlled trial is designed to investigate the effect of low-dose dexmedetomidine on 1-year survival and the quality of life of 1-year survivors in elderly patients admitted to the ICU after surgery.

02

Conditions studied

  • Elderly
  • Surgery
  • Intensive Care Unit
  • Dexmedetomidine
  • Overall Survival

Keywords

  • Elderly
  • Surgery
  • Intensive Care Unit
  • Dexmedetomidine
  • Overall survival
03

In context

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,410 participants (actual)

Study arms

  • Experimental
    Dexmedetomidine group

    Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days.

    Drug: Dexmedetomidine

  • Placebo comparator
    Placebo group

    Normal saline is infused for the same duration as in the dexmedetomidine group.

    Drug: Placebo

Interventions

  • DrugDexmedetomidine

    1. Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days. 2. For non-intubated patients, the infusion rate is adjusted to reach a Richmond Agitation-Sedation Scale (RASS) of -1, or a maximal rate of 0.2 microgram/kg/h, or the occurrence of any adverse events. 3. For intubated patients, the infusion rate is adjusted to reach a RASS of -1, or a maximal rate of 0.7 microgram/kg/h, or the occurrence of any adverse events.

  • DrugPlacebo

    1. Normal saline is infused in the same rate for the same duration as in the dexmedetomidine group. 2. Propofol sedation is administered when considered necessary.

    Also known as: Normal saline

06

What researchers measure

Primary outcomes

  1. Overall survival after surgery

    Overall survival after surgery

    Time frame: Up to 4 years after surgery

Secondary outcomes

  1. The incidence of organ injury within 5 days after surgery

    Organ injury include delirium (assessed with Confusion Assessment Method/CAM for the Intensive Care Unit), acute kidney injury (assessed with KIDGO criteria), and myocardial injury (assessed with cardiac troponin I).

    Time frame: Up to 5 days after surgery

  2. Length of stay in the intensive care unit (ICU) stay after surgery

    Length of ICU stay after surgery

    Time frame: Up to 30 days after surgery

  3. Length of stay in hospital after surgery

    Length of stay in hospital after surgery

    Time frame: Up to 30 days after surgery

  4. Incidence of postoperative complications within 30 days after surgery

    Postoperative complications are defined as newly occured medical events that are harmful to patients' recovery and required interventional therapy.

    Time frame: Up to 30 days after surgery

  5. Rate of all-cause 30-day mortality after surgery

    All-cause 30-day mortality after surgery

    Time frame: Up to 30 days after surgery

  6. Sleep quality at 30 days after surgery

    The sleep quality is assessed with the Pittsburgh Sleep Quality Index Questionnaire (PSQI, score ranges from 0 to 21, with higher score indicating poorer sleep quality).

    Time frame: At 30 days after surgery

  7. Recurrence-free survival after surgery

    Recurrence-free survival after surgery

    Time frame: Up to 4 year after surgery

  8. Event-free survival after surgery

    Event-free survival after surgery

    Time frame: Up to 4 year after surgery

  9. Cancer-specific survival after surgery

    Cancer-specific survival after surgery

    Time frame: Up to 4 year after surgery

  10. Quality of life in 1-year survivors after surgery

    The quality of life is assessed with the World Health Organization Quality of Life Questionaire abbreviated version (WHOQOL-BREF, a 24-item questionnaire that provides assessments of the quality of life in physical, psychological, and social relationship, and environmental domains. For each domain, the score ranges from 0 to 100, with higher score indicating better function).

    Time frame: At the end the 1st year after surgery

Other outcomes

  1. Pain severity within 5 days after surgery: Numeric Rating Scale

    Pain severity is assessed with the Numeric Rating Scale (an 11-point scale where 0=no pain and 10=the worst pain.

    Time frame: Up to 5 days after surgery.

  2. Subjective sleep quality within 5 days after surgery: Numeric Rating Scale

    Subjective sleep quality the Numeric Rating Scale (an 11-point scale where 0=the best sleep and 10=the worst sleep.

    Time frame: Assessed in the morning on the 1st, 2nd, 3rd, 4th, and 5th day after surgery

  3. Overall survival after surgery in cancer patients

    Overall survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

  4. Recurrence-free survival after surgery in cancer patients

    Recurrence-free survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

  5. Event-free survival after surgery in cancer patients

    Event-free survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

  6. Cancer-specific survival after surgery in cancer patients

    Cancer-specific survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

07

Study locations

1 site
  • Peking University First Hospital
    Beijing, Beijing Municipality 100034, China
08

References and documents

Publications

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  • Cooper AB, Thornley KS, Young GB, Slutsky AS, Stewart TE, Hanly PJ. Sleep in critically ill patients requiring mechanical ventilation. Chest. 2000 Mar;117(3):809-18. doi: 10.1378/chest.117.3.809. PubMed 10713011 ↗
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Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04204798
Lead sponsor
Peking University First Hospital
Collaborators
Peking University Third Hospital, Beijing Hospital
Responsible party
Dong-Xin Wang (Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital) — Principal investigator
First posted
Dec 19, 2019
Start date
Aug 28, 2020
Primary completion
Jun 4, 2025
Completion
Jun 4, 2026 (estimated)
Last update
Jul 31, 2025

Study contacts

Dong-Xin Wang, MD, PhD
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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