Effects of dexmedetomidine and esketamine on sleep after cardiac surgery
Official title: Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Run by Nanjing First Hospital, Nanjing Medical University · NCT06778811 · Data updated 2026-11-12
This study tests whether the medications dexmedetomidine or esketamine can help improve sleep for people recovering from heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Status | Recruiting |
| Started | October 11, 2024 |
| Main results expected | September 2025 |
| Study ends | September 2025 |
| Registry record updated | February 7, 2025 |
| Trial ID | NCT06778811 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients classified as ASA class II-III and NYHA class I-III, with an ejection fraction of 50% or greater, who are scheduled for cardiac surgery requiring extracorporeal circulation.
✕Probably not a fit
Patients with a history of sleep disorders, significant hepatic or renal dysfunction, or those undergoing second heart surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates how dexmedetomidine and esketamine influence postoperative sleep disturbances in patients undergoing cardiac surgery. Participants will receive either dexmedetomidine, esketamine, or a saline control during surgery, followed by assessments of their sleep quality on the first and third postoperative days. The study aims to determine which of the two medications is more effective in preventing sleep issues after surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and sleep quality for cardiac surgery patients.
How similar studies have gone: While the specific combination of dexmedetomidine and esketamine for this purpose may be novel, similar studies have shown that managing postoperative sleep disturbances can significantly enhance recovery outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA class II-III, NYHA class I-III, EF ≥ 50% 2. Intended to perform cardiac surgery under extracorporeal circulation Exclusion Criteria: 1. Patients undergoing second heart surgery 2. Patients with mental retardation, deafness, or other conditions that interfere with normal communication 3. Previous neurological or psychiatric disorders 4. Patients with a history of sleep disorders 5. Alcoholics, drug addicts, or psychotropic substance abusers 6. Significant hepatic or renal dysfunction affecting drug metabolism 7. Contraindication to the use of dexmedetomidine or esketamine.
Where it's running
-
Nanjing First Hospital
Nanjing, Jiangsu, China Recruiting -
Nanjing First Hospital,Nanjing Medical University
Nanjing, Jiangsu, China Not yet recruiting
Study contacts
- Study coordinator: Kuang xueyi
- Email: kxy809707496@126.com
- Phone: 86+18651908072
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.