Actively Recruiting
Clinical Study Evaluating Dexmedetomidine and Esketamine for Sleep Disorders After Cardiac Surgery
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-02-07
180
Participants Needed
2
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of dexmedetomidine and esketamine on sleep quality after cardiac surgery. This phase 4 clinical trial aims to find out if these drugs can prevent postoperative sleep disturbances and to compare their effectiveness against saline, a drug-free control. The study focuses on patients undergoing cardiac surgery with specific heart and health classifications. During surgery, participants receive a continuous infusion of either dexmedetomidine at 0.3 micrograms per kilogram per hour, esketamine at 0.3 milligrams per kilogram per hour, or saline in equal volumes. This infusion continues until the end of the surgery. The study compares these three groups to assess their impact on sleep. Participants' sleep quality is measured using a sleep rating scale on the first and third days after surgery. The study monitors sleep disturbances to understand recovery quality. The trial includes adults aged 40 to 75 years undergoing cardiac surgery with extracorporeal circulation, with careful assessment to ensure safety and eligibility.
CONDITIONS
Official Title
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA class II-III
- NYHA class I-III
- Ejection fraction (EF) of 50% or higher
- Planned cardiac surgery using extracorporeal circulation
- Age between 40 and 75 years
You will not qualify if you...
- Undergoing a second heart surgery
- Mental retardation, deafness, or communication impairments
- Previous neurological or psychiatric disorders
- History of sleep disorders
- Alcohol, drug, or psychotropic substance abuse
- Significant liver or kidney dysfunction affecting drug metabolism
- Contraindication to dexmedetomidine or esketamine use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nanjing First Hospital，Nanjing Medical University
Nanjing, Jiangsu, China, 210006
Not Yet Recruiting
2
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
K
Kuang xueyi
H
hongwei shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here