Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- Sleep Quality
Study Overview
Brief 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? 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA class II-III, NYHA class I-III, EF ≥ 50%
- •Intended to perform cardiac surgery under extracorporeal circulation
Exclusion Criteria
- •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.
Arms & Interventions
dexmedetomidine group
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
Intervention: Intraoperative infusion of dexmedetomidine (Drug)
esketamine group
Intraoperative infusion of 0.3mg/kg/h esketamine
Intervention: Intraoperative infusion of esketamine (Drug)
control group
Intraoperative infusion of equal volumes of saline
Intervention: Saline control (Drug)
Outcomes
Primary Outcomes
Sleep Quality
Time Frame: 1, 3, 7days after surgery
Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device
Secondary Outcomes
- anxiety and depression assessment(1,3 days after surgery)
- Postoperative complications(48 hours after surgery)
- postoperative pain(24 hours and 48 hours after surgery)
- Record postoperative analgesic medications used and the amount used for postoperative pain(24 hours and 48 hours after surgery)
- Postoperative delirium(from 1 day to 7 days after surgery)