Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery
NCT ID: NCT04204798
Last Updated: 2025-07-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
1410 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-28
Study Completion Date
2026-06-04
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Elderly
Surgery
Intensive Care Unit
Dexmedetomidine
Overall Survival
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Dexmedetomidine group
Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days.
Group Type
EXPERIMENTAL
Dexmedetomidine
Intervention Type
DRUG
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.
Placebo group
Normal saline is infused for the same duration as in the dexmedetomidine group.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
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.
Interventions
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Dexmedetomidine
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.
Intervention Type
DRUG
Placebo
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.
Intervention Type
DRUG
Other Intervention Names
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Normal saline
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Peking University Third Hospital
OTHER
Sponsor Role
collaborator
Beijing Hospital
OTHER_GOV
Sponsor Role
collaborator
Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Site Status
Countries
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China
References
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Other Identifiers
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2019-226
Identifier Type: -
Identifier Source: org_study_id
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