Effects of dexmedetomidine and esketamine on sleep after cardiac surgery
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
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 |
| Enrollment | 180 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06778811 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu and 1 other locations
- Nanjing First Hospital，Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Kuang xueyi
- Email: kxy809707496@126.com
- Phone: 86+18651908072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.