Actively Recruiting
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-02-07
180
Participants Needed
2
Research Sites
N/A
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 heart surgery. The study aims to find out if these drugs can prevent postoperative sleep disturbances and which is more effective, comparing them to a saline placebo. This is a Phase 4 randomized trial focused on patients undergoing cardiac surgery with extracorporeal circulation. Participants are randomly assigned to receive an intraoperative continuous infusion of either dexmedetomidine at 0.3 ug/kg/h, esketamine at 0.3 mg/kg/h, or saline until the surgery ends. The study involves three groups: a dexmedetomidine group, an esketamine group, and a saline control group. The infusion happens during surgery only. During the first and third days after surgery, participants' sleep is assessed using a sleep rating scale. Researchers also monitor pain levels at 24 and 48 hours, use of pain medications, anxiety and depression at 1 and 3 days, postoperative complications at 48 hours, and delirium from day 1 to 7. The study runs from October 2024 to September 2025 and involves detailed monitoring of recovery quality and sleep outcomes.
CONDITIONS
Brief Title
Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA class II-III and NYHA class I-III with ejection fraction 50% or higher
- Scheduled for cardiac surgery using extracorporeal circulation
- Age between 40 and 75 years
You will not qualify if you...
- Patients undergoing second heart surgery
- Mental retardation, deafness, or conditions affecting communication
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During surgery
Participants receive an intraoperative infusion of either dexmedetomidine, esketamine, or saline during cardiac surgery.
1 surgery visit (in-person)
Duration - 7 days after surgery
Participants are monitored for sleep quality, pain, anxiety, depression, delirium, and postoperative complications after surgery.
Visits on days 1, 3, and 7 after surgery, and assessments at 24 and 48 hours
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
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