Sleep Wake DisordersPhase 4NCT06778811
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
A Phase 4 study testing Intraoperative infusion of dexmedetomidine and Intraoperative infusion of esketamine in people with Sleep Wake Disorders and Esketamine and the Quality of Recovery, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
Trial summary
The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are: Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better?… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Sleep Wake Disorders, Esketamine and the Quality of Recovery, Dexmedetomidine
- What is being tested?
- Intraoperative infusion of dexmedetomidine and Intraoperative infusion of esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2024to Sep 2025
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class II-III, NYHA class I-III, EF ≥ 50%
- Intended to perform cardiac surgery under extracorporeal circulation
Who cannot join
- Patients undergoing second heart surgery
- Patients with mental retardation, deafness, or other conditions that interfere with normal communication
- Previous neurological or psychiatric disorders
- Patients with a history of sleep disorders
- Alcoholics, drug addicts, or psychotropic substance abusers
- Significant hepatic or renal dysfunction affecting drug metabolism
- Contraindication to the use of dexmedetomidine or esketamine.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Nanjing First Hospital，Nanjing Medical University
Nanjing, Jiangsu, 210006
kuang xueyi, 86+18651908072, kxy809707496@163.com
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
zhang ying, Master degree, 86+15380998716, 1070434273@qq.com
shi hong wei, Doctor degree
About this study
The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:
Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.
Read more
Participants will:
- Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery
- Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale
- Being tested
- Intraoperative infusion of dexmedetomidine, Intraoperative infusion of esketamine, Saline control
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative infusion of dexmedetomidineDrug
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
Intraoperative infusion of esketamineDrug
Intraoperative infusion of 0.3mg/kg/h esketamine
Saline controlDrug
Intraoperative infusion of equal volumes of saline
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine group | Experimental | Intraoperative infusion of 0.3ug/kg/h dexmedetomidine Receives: Drug: Intraoperative infusion of dexmedetomidine |
| esketamine group | Experimental | Intraoperative infusion of 0.3mg/kg/h esketamine Receives: Drug: Intraoperative infusion of esketamine |
| control group | Placebo comparator | Intraoperative infusion of equal volumes of saline Receives: Drug: Saline control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device
Measured: 1, 3, 7days after surgery
Secondary outcomes (5)
postoperative pain
Assessment of postoperative pain levels by Visual Analogue Scale（VAS），from 0 to 10, Higher scores mean more severe pain，VAS>4 means positive.
Measured: 24 hours and 48 hours after surgery
Record postoperative analgesic medications used and the amount used for postoperative pain
Record postoperative analgesic medications used and the amount used
Measured: 24 hours and 48 hours after surgery
anxiety and depression assessment
Assessment of anxiety and depression levels by Hospital anxiety and depression scale (HADS)，0-7 is negative; 8-10 is mild; 11-14 is moderate; 15-21 is severe.
Measured: 1,3 days after surgery
Postoperative complications
including nausea and vomiting, dizziness, itching, nightmares and so on.
Measured: 48 hours after surgery
Postoperative delirium
Assessment of Postoperative delirium by Confusion Assessment Method (CAM)，scores > 21 is positive.
Measured: from 1 day to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start11 Oct 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Wake DisordersStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778811
- Sponsor's protocol ID
- KY20240924-05
- Status last verified
- Feb 2025
- First submitted
- 23 Dec 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06778811
- Acronym / sponsor ID
- KY20240924-05
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 16 Jan 2025 (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.
The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:
Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.
Participants will:
- Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery
- Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine group | Experimental | Drug: Intraoperative infusion of dexmedetomidineIntraoperative infusion of 0.3ug/kg/h dexmedetomidine |
| esketamine group | Experimental | Drug: Intraoperative infusion of esketamineIntraoperative infusion of 0.3mg/kg/h esketamine |
| control group | Placebo comparator | Drug: Saline controlIntraoperative infusion of equal volumes of saline |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA class II-III, NYHA class I-III, EF ≥ 50%
- Intended to perform cardiac surgery under extracorporeal circulation
Key exclusion criteria (7 listed)
- Patients undergoing second heart surgery
- Patients with mental retardation, deafness, or other conditions that interfere with normal communication
- Previous neurological or psychiatric disorders
- Patients with a history of sleep disorders
- Alcoholics, drug addicts, or psychotropic substance abusers
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 |
|---|---|---|
| Intraoperative infusion of dexmedetomidineIntraoperative infusion of 0.3ug/kg/h dexmedetomidine | Drug | dexmedetomidine group |
| Intraoperative infusion of esketamineIntraoperative infusion of 0.3mg/kg/h esketamine | Drug | esketamine group |
| Saline controlIntraoperative infusion of equal volumes of saline | Drug | control group |
Primary outcome
Sleep Quality
Time frame: 1, 3, 7days after surgery
Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device
5 secondary outcomes
postoperative pain
Time frame: 24 hours and 48 hours after surgery
Record postoperative analgesic medications used and the amount used for postoperative pain
Time frame: 24 hours and 48 hours after surgery
anxiety and depression assessment
Time frame: 1,3 days after surgery
Postoperative complications
Time frame: 48 hours after surgery
Postoperative delirium
Time frame: from 1 day to 7 days 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 7 Feb 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intraoperative infusion of dexmedetomidine and Intraoperative infusion of esketamine in people with Sleep Wake Disorders and Esketamine and the Quality of Recovery, run by Nanjing First Hospital, Nanjing Medical University at 2 sites 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kuang xueyi (86+18651908072, kxy809707496@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: 1, 3, 7days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.