ElderlyNCT04204798

Dexmedetomidine and Outcomes of Elderly Admitted to ICU After Surgery

A study testing Dexmedetomidine in people with Elderly and Surgery, run by Peking University First Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: Elderly, Surgery, Intensive Care Unit
What is being tested?: Dexmedetomidine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,410 participants
Where: 1 siteChina
Study dates: 28 Aug 2020to 4 Jun 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

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

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.

Conditions: Elderly, Surgery, Intensive Care Unit, Dexmedetomidine, Overall Survival
Being tested: Dexmedetomidine, Placebo
Keywords: Elderly, Surgery, Intensive Care Unit, Dexmedetomidine, Overall survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
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.
PlaceboDrug
Also called Normal saline
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.

Study groups in NCT04204798
Study group	Role	What they receive
Dexmedetomidine group	Experimental	Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days. Receives: Drug: Dexmedetomidine
Placebo group	Placebo comparator	Normal saline is infused for the same duration as in the dexmedetomidine group. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival after surgery
Overall survival after surgery
Measured: Up to 4 years after surgery

Secondary outcomes (10)

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).
Measured: Up to 5 days after surgery
Length of stay in the intensive care unit (ICU) stay after surgery
Length of ICU stay after surgery
Measured: Up to 30 days after surgery
Length of stay in hospital after surgery
Length of stay in hospital after surgery
Measured: Up to 30 days after surgery
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.
Measured: Up to 30 days after surgery
Rate of all-cause 30-day mortality after surgery
All-cause 30-day mortality after surgery
Measured: Up to 30 days after surgery
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).
Measured: At 30 days after surgery
Recurrence-free survival after surgery
Recurrence-free survival after surgery
Measured: Up to 4 year after surgery
Event-free survival after surgery
Event-free survival after surgery
Measured: Up to 4 year after surgery
Cancer-specific survival after surgery
Cancer-specific survival after surgery
Measured: Up to 4 year after surgery
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).
Measured: At the end the 1st year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20204 Jun 2026

First posted19 Dec 2019
Study start28 Aug 2020
Primary completion4 Jun 2025
Study completion4 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (46)Papers the sponsor has linked to this study.
Other trials for ElderlyStudies of the same condition, open and under way.
More trials run by Peking University First HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,410 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04204798
Sponsor's protocol ID: 2019-226
Status last verified: Jul 2025
First submitted: 17 Dec 2019
Last updated: 31 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Novaes MA, Knobel E, Bork AM, Pavao OF, Nogueira-Martins LA, Ferraz MB. Stressors in ICU: perception of the patient, relatives and health care team. Intensive Care Med. 1999 Dec;25(12):1421-6. doi: 10.1007/s001340051091.
PubMed 10660851
Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52. doi: 10.1097/00003246-200204000-00004.
PubMed 11940739
Simini B. Patients' perceptions of intensive care. Lancet. 1999 Aug 14;354(9178):571-2. doi: 10.1016/S0140-6736(99)02728-2.
PubMed 10470711
Drouot X, Roche-Campo F, Thille AW, Cabello B, Galia F, Margarit L, d'Ortho MP, Brochard L. A new classification for sleep analysis in critically ill patients. Sleep Med. 2012 Jan;13(1):7-14. doi: 10.1016/j.sleep.2011.07.012. Epub 2011 Dec 6.
PubMed 22153778
Gabor JY, Cooper AB, Hanly PJ. Sleep disruption in the intensive care unit. Curr Opin Crit Care. 2001 Feb;7(1):21-7. doi: 10.1097/00075198-200102000-00004.
PubMed 11373507
Freedman NS, Gazendam J, Levan L, Pack AI, Schwab RJ. Abnormal sleep/wake cycles and the effect of environmental noise on sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 2001 Feb;163(2):451-7. doi: 10.1164/ajrccm.163.2.9912128.
PubMed 11179121
Elliott R, McKinley S, Cistulli P, Fien M. Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.
PubMed 23506782
Aurell J, Elmqvist D. Sleep in the surgical intensive care unit: continuous polygraphic recording of sleep in nine patients receiving postoperative care. Br Med J (Clin Res Ed). 1985 Apr 6;290(6474):1029-32. doi: 10.1136/bmj.290.6474.1029.
PubMed 3921096
Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.
PubMed 12598213
Esquinas AM, Papadakos PJ, Schwartz AR. Sleep patterns during long-term mechanical ventilation in tracheostomized patients in the ICU: do they matter? Crit Care Med. 2014 Jan;42(1):e82-3. doi: 10.1097/CCM.0b013e3182a84ccd. No abstract available.
PubMed 24346550
Day A, Haj-Bakri S, Lubchansky S, Mehta S. Sleep, anxiety and fatigue in family members of patients admitted to the intensive care unit: a questionnaire study. Crit Care. 2013 May 24;17(3):R91. doi: 10.1186/cc12736.
PubMed 23705988
Hu RF, Jiang XY, Zeng YM, Chen XY, Zhang YH. Effects of earplugs and eye masks on nocturnal sleep, melatonin and cortisol in a simulated intensive care unit environment. Crit Care. 2010;14(2):R66. doi: 10.1186/cc8965. Epub 2010 Apr 18.
PubMed 20398302
Kondili E, Alexopoulou C, Xirouchaki N, Georgopoulos D. Effects of propofol on sleep quality in mechanically ventilated critically ill patients: a physiological study. Intensive Care Med. 2012 Oct;38(10):1640-6. doi: 10.1007/s00134-012-2623-z. Epub 2012 Jul 3.
PubMed 22752356
Hardin KA, Seyal M, Stewart T, Bonekat HW. Sleep in critically ill chemically paralyzed patients requiring mechanical ventilation. Chest. 2006 Jun;129(6):1468-77. doi: 10.1378/chest.129.6.1468.
PubMed 16778263
Roberts B, Rickard CM, Rajbhandari D, Turner G, Clarke J, Hill D, Tauschke C, Chaboyer W, Parsons R. Multicentre study of delirium in ICU patients using a simple screening tool. Aust Crit Care. 2005 Feb;18(1):6, 8-9, 11-4 passim. doi: 10.1016/s1036-7314(05)80019-0.
PubMed 18038529

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Elderly trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Low-dose Dexmedetomidine on Outcomes of Elderly Admitted to ICU After Noncardiac Surgery: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04204798
Acronym / sponsor ID: 2019-226
Conditions: Elderly, Surgery, Intensive Care Unit, Dexmedetomidine, Overall Survival
Keywords: Elderly, Surgery, Intensive Care Unit, Dexmedetomidine, Overall survival
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,410 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Collaborators: Peking University Third Hospital, Beijing Hospital
Study start: 28 Aug 2020 (actual)
Primary completion: 4 Jun 2025 (actual)
Study completion: 4 Jun 2026 (estimated)
First posted: 19 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dexmedetomidine group	Experimental	Drug: DexmedetomidineDexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days.
Placebo group	Placebo comparator	Drug: PlaceboNormal saline is infused for the same duration as in the dexmedetomidine group.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dexmedetomidine1. 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.	Drug	Dexmedetomidine group
PlaceboAlso: Normal saline1. 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.	Drug	Placebo group

Primary outcome

Overall survival after surgery
Time frame: Up to 4 years after surgery
Overall survival after surgery

10 secondary outcomes

The incidence of organ injury within 5 days after surgery
Time frame: Up to 5 days after surgery
Length of stay in the intensive care unit (ICU) stay after surgery
Time frame: Up to 30 days after surgery
Length of stay in hospital after surgery
Time frame: Up to 30 days after surgery
Incidence of postoperative complications within 30 days after surgery
Time frame: Up to 30 days after surgery
Rate of all-cause 30-day mortality after surgery
Time frame: Up to 30 days after surgery
Sleep quality at 30 days after surgery
Time frame: At 30 days after surgery
Recurrence-free survival after surgery
Time frame: Up to 4 year after surgery
Event-free survival after surgery
Time frame: Up to 4 year after surgery
Cancer-specific survival after surgery
Time frame: Up to 4 year after surgery
Quality of life in 1-year survivors after surgery
Time frame: At the end the 1st year after surgery

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
Background: PubMed 10660851Novaes MA, Knobel E, Bork AM, Pavao OF, Nogueira-Martins LA, Ferraz MB. Stressors in ICU: perception of the patient, relatives and health care team. Intensive Care Med. 1999 Dec;25(12):1421-6. doi: 10.1007/s001340051091.
Background: PubMed 11940739Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52. doi: 10.1097/00003246-200204000-00004.
Background: PubMed 10470711Simini B. Patients' perceptions of intensive care. Lancet. 1999 Aug 14;354(9178):571-2. doi: 10.1016/S0140-6736(99)02728-2.
Background: PubMed 22153778Drouot X, Roche-Campo F, Thille AW, Cabello B, Galia F, Margarit L, d'Ortho MP, Brochard L. A new classification for sleep analysis in critically ill patients. Sleep Med. 2012 Jan;13(1):7-14. doi: 10.1016/j.sleep.2011.07.012. Epub 2011 Dec 6.
Background: PubMed 11373507Gabor JY, Cooper AB, Hanly PJ. Sleep disruption in the intensive care unit. Curr Opin Crit Care. 2001 Feb;7(1):21-7. doi: 10.1097/00075198-200102000-00004.
Background: PubMed 11179121Freedman NS, Gazendam J, Levan L, Pack AI, Schwab RJ. Abnormal sleep/wake cycles and the effect of environmental noise on sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 2001 Feb;163(2):451-7. doi: 10.1164/ajrccm.163.2.9912128.
Background: PubMed 23506782Elliott R, McKinley S, Cistulli P, Fien M. Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.
Background: PubMed 3921096Aurell J, Elmqvist D. Sleep in the surgical intensive care unit: continuous polygraphic recording of sleep in nine patients receiving postoperative care. Br Med J (Clin Res Ed). 1985 Apr 6;290(6474):1029-32. doi: 10.1136/bmj.290.6474.1029.
Background: PubMed 12598213Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15. doi: 10.1164/rccm.2201090.
Background: PubMed 24346550Esquinas AM, Papadakos PJ, Schwartz AR. Sleep patterns during long-term mechanical ventilation in tracheostomized patients in the ICU: do they matter? Crit Care Med. 2014 Jan;42(1):e82-3. doi: 10.1097/CCM.0b013e3182a84ccd. No abstract available.
Background: PubMed 23705988Day A, Haj-Bakri S, Lubchansky S, Mehta S. Sleep, anxiety and fatigue in family members of patients admitted to the intensive care unit: a questionnaire study. Crit Care. 2013 May 24;17(3):R91. doi: 10.1186/cc12736.
Background: PubMed 20398302Hu RF, Jiang XY, Zeng YM, Chen XY, Zhang YH. Effects of earplugs and eye masks on nocturnal sleep, melatonin and cortisol in a simulated intensive care unit environment. Crit Care. 2010;14(2):R66. doi: 10.1186/cc8965. Epub 2010 Apr 18.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dong-Xin Wang, MD, PhD principal investigator

Peking University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine in people with Elderly and Surgery, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival after surgery (time frame: Up to 4 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204798, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.