Effect of Perioperative Dezocine Administration on Postoperative Delirium in Elderly Patients Undergoing Cardiopulmonary Bypass Cardiac Surgery: A Randomized Controlled Trial
| Registry | NCT07768150 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 640 (Estimated) |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital (Other) |
| Conditions | Postoperative Delirium (POD) |
| Interventions | Dezocine, Normal Saline (NS) (Drug) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-12-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-08-17, last updated 2026-08-17 |
| Locations | 2 sites in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Delirium (POD) All trials of Dezocine All trials of Normal Saline (NS)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dezocine Group | Experimental | Drug: Dezocine | |
| Normal Saline Control Group | Active comparator | Drug: Normal Saline (NS) |
Sex: All, ages: 65 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing, Beijing Municipality | China | |
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | China |