Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative infusion of dexmedetomidine, Intraoperative infusion of esketamine, Saline control.
- Who it may be relevant to
- Registry conditions: Sleep Wake Disorders, Esketamine and the Quality of Recovery, Dexmedetomidine. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Intraoperative infusion of dexmedetomidine
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine - Drug Intraoperative infusion of esketamine
Intraoperative infusion of 0.3mg/kg/h esketamine - Drug Saline control
Intraoperative infusion of equal volumes of saline
Primary outcome measures
- Sleep Quality [Time frame: 1, 3, 7days after surgery]
Secondary outcome measures (5)
- postoperative pain [Time frame: 24 hours and 48 hours after surgery]
- Record postoperative analgesic medications used and the amount used for postoperative pain [Time frame: 24 hours and 48 hours after surgery]
- anxiety and depression assessment [Time frame: 1,3 days after surgery]
- Postoperative complications [Time frame: 48 hours after surgery]
- Postoperative delirium [Time frame: from 1 day to 7 days after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 2 centers
- Nanjing First Hospital，Nanjing Medical University — Nanjing
- Nanjing First Hospital — Nanjing
Identifiers
NCT: NCT06778811 · KY20240924-05