Cardiac surgery with cardiopulmonary bypass
Conditions
Interventions
Trial group:Dilute esketamine with 50 mL of 0.9% saline to a concentration of 1 mg/mL. Administer esketamine 0.25 mg/kg intravenously 5 min after endotracheal intubation, followed by continuous infusi
discontinue the infusion at the end of surgery.
Control group:Dilute with 50 mL of 0.9% saline. At 5 min after endotracheal intubation, administer placebo group 0.25 mL/kg (equal volume) of normal saline intravenously, followed by continuous infusi
Sponsors
First Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged >=18 years undergoing elective cardiac surgery with cardiopulmonary bypass via median sternotomy; 2. American Society of Anesthesiologists (ASA) physical status classification II–IV; 3. New York Heart Association (NYHA) functional class II–III; 4. Body mass index (BMI) 18–30 kg/m^2; 5. Written informed consent signed by the participant.
Exclusion criteria
Exclusion criteria: 1. Aortic dissection surgery 2. Contraindications to esketamine use (glaucoma, history of hyperthyroidism, risk of increased intracranial pressure) 3. Known psychiatric disorders 4. History of dementia or preoperative Mini-Mental State Examination (MMSE) indicating cognitive impairment (based on educational level: illiterate =1.5 mg/L or requiring dialysis) 9. Uncontrolled hypertension (baseline systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium within 7 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first onset of delirium;Subtypes of delirium;Postoperative pain;Postoperative sleep quality;Postoperative anxiety and depression;Safety outcomes (all-cause mortality during postoperative hospitalization, new-onset myocardial infarction, postoperative stroke, acute kidney injury); incidence of esketamine-associated adverse reactions within the first 3 postoperative days, including nightmares, hallucinations, and blurred vision;Postoperative mechanical ventilation time;ICU stay time;Duration of delirium; | — |
Countries
China
Contacts
Public ContactHou Lihong
First Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed