Postoperative Delirium (POD)
Conditions
Keywords
Dezocine, Postoperative delirium, Cardiopulmonary bypass, Cardiac surgery
Brief summary
Postoperative delirium (POD) is a common complication in elderly patients undergoing cardiac surgery and is associated with prolonged hospitalization, increased morbidity, and poor recovery. Currently, effective pharmacological strategies for preventing POD remain limited. This study aims to evaluate whether perioperative administration of dezocine can reduce the incidence of postoperative delirium in elderly patients undergoing cardiopulmonary bypass cardiac surgery. This is a prospective, randomized, controlled clinical trial conducted at Fuwai Hospital. Eligible patients aged 65 years or older undergoing elective cardiopulmonary bypass cardiac surgery will be randomly assigned to receive either dezocine or normal saline control in a 1:1 ratio. Patients in the dezocine group will receive intravenous dezocine (0.1 mg/kg) before anesthesia induction and again before transfer out of the operating room. At each administration time point, dezocine will be diluted with normal saline to a total volume of 6 mL and infused intravenously over 3 minutes. Patients in the control group will receive equivalent volumes of normal saline at the corresponding time points. The primary outcome is the incidence of postoperative delirium within 7 days after surgery. Secondary outcomes include delirium characteristics, postoperative recovery outcomes, pain scores, opioid consumption, sedation status, and perioperative complications. This study will investigate the potential role of dezocine as a preventive strategy for postoperative delirium in high-risk elderly cardiac surgery patients.
Interventions
DRUGDezocine
Dezocine will be administered intravenously at a dose of 0.1 mg/kg before anesthesia induction and before transfer out of the operating room. At each administration time point, dezocine will be diluted with 0.9% normal saline to a total volume of 6 mL and infused over 3 minutes.
An equivalent volume of 0.9% normal saline will be administered intravenously at the same time points as the dezocine group, with the same infusion volume and administration procedure.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥65 years. 2. Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass. 3. Ability to complete preoperative cognitive assessment. 4. Written informed consent provided by the patient or legally authorized representative.
Exclusion criteria
1. Pre-existing neurological or psychiatric disorders that may affect postoperative delirium assessment, including dementia, active delirium, severe psychiatric disorders, recent stroke, or other severe neurological diseases. 2. Severe visual or hearing impairment or other conditions preventing postoperative delirium assessment. 3. Long-term use of opioid analgesics or sedative-hypnotic medications, or known allergy to dezocine. 4. Severe hepatic or renal dysfunction. 5. Emergency surgery, redo sternotomy, aortic surgery, or complex combined cardiac surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative delirium within 7 days after surgery | Within 7 days after surgery |
Countries
China
Contacts
CONTACTKexin Liu
Outcome results
None listed