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NCT Number: NCT04204798

Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

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

Placebo

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

Other names: Normal saline

Primary outcomes

  1. Overall survival after surgery

    Time frame: Up to 4 years after surgery

    Overall survival after surgery

Secondary outcomes

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

    Time frame: Up to 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).

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

    Time frame: Up to 30 days after surgery

    Length of ICU stay after surgery

  3. Length of stay in hospital after surgery

    Time frame: Up to 30 days after surgery

    Length of stay in hospital after surgery

  4. Incidence of postoperative complications within 30 days after surgery

    Time frame: Up to 30 days after surgery

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

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

    Time frame: Up to 30 days after surgery

    All-cause 30-day mortality after surgery

  6. Sleep quality at 30 days after surgery

    Time frame: 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).

  7. Recurrence-free survival after surgery

    Time frame: Up to 4 year after surgery

    Recurrence-free survival after surgery

  8. Event-free survival after surgery

    Time frame: Up to 4 year after surgery

    Event-free survival after surgery

  9. Cancer-specific survival after surgery

    Time frame: Up to 4 year after surgery

    Cancer-specific survival after surgery

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

    Time frame: At the end the 1st year 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).

Other outcomes

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

    Time frame: Up to 5 days after surgery.

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

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

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

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

  3. Overall survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

    Overall survival after surgery in cancer patients

  4. Recurrence-free survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

    Recurrence-free survival after surgery in cancer patients

  5. Event-free survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

    Event-free survival after surgery in cancer patients

  6. Cancer-specific survival after surgery in cancer patients

    Time frame: Up to 4 year after surgery

    Cancer-specific survival after surgery in cancer patients

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Beijing Hospital
  • Peking University Third Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Dec 19, 2019
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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