Sleep Wake Disorders, Esketamine and the Quality of Recovery, Dexmedetomidine
Conditions
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: 1. Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery 2. Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale
Interventions
DRUGIntraoperative infusion of dexmedetomidine
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
DRUGIntraoperative infusion of esketamine
Intraoperative infusion of 0.3mg/kg/h esketamine
DRUGSaline control
Intraoperative infusion of equal volumes of saline
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 1, 3, 7days after surgery | Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 24 hours and 48 hours after surgery | Assessment of postoperative pain levels by Visual Analogue Scale（VAS），from 0 to 10, Higher scores mean more severe pain，VAS\>4 means positive. |
| Record postoperative analgesic medications used and the amount used for postoperative pain | 24 hours and 48 hours after surgery | Record postoperative analgesic medications used and the amount used |
| anxiety and depression assessment | 1,3 days after surgery | Assessment of anxiety and depression levels by Hospital anxiety and depression scale (HADS)，0-7 is negative; 8-10 is mild; 11-14 is moderate; 15-21 is severe. |
| Postoperative complications | 48 hours after surgery | including nausea and vomiting, dizziness, itching, nightmares and so on. |
| Postoperative delirium | from 1 day to 7 days after surgery | Assessment of Postoperative delirium by Confusion Assessment Method (CAM)，scores \> 21 is positive. |
Countries
China
Contacts
Primary ContactKuang xueyi
Backup Contacthongwei shi
Outcome results
None listed