Colonic Neoplasms, Fractures, Bone, Gynecologic Cancer, Kidney Neoplasms, Liver Neoplasms, Osteoarthropathy, Prostatic Neoplasms, Rectal Neoplasms, Sigmoid Neoplasms, Stomach Neoplasms, Urinary Bladder Neoplasms
Conditions
Keywords
Postoperative delirium, Neuroleptanalgesia, Aged, Noncardiac major surgery
Brief summary
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
Interventions
DRUGlow-dose neuroleptanalgesia
Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.
DRUGPlacebo
The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.
Sponsors
Shanghai 8th People's Hospital
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 65 years old and ≤ 85 years old; 2. Selective non-cardiac major surgery; 3. Informed consent and voluntary participation in the trial; 4. ASA class I-II; 5. Anticipated operation duration ≥ 2 hours; 6. No plan to ICU after operation.
Exclusion criteria
1. Neurosurgery; 2. Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc; 3. Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia; 4. Patients with severe cardiopulmonary disease, liver and kidney dysfunction; 5. Allergic or contraindications to droperidol or fentanyl citrate; 6. Admitted to ICU after operation. 7. Operation duration \< 2 hours;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery | Up to 7 days after surgery（or leaving hospital） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | Up to 7 days after surgery（or leaving hospital） | — |
| Patients' satisfaction | Up to 7 days after surgery（or leaving hospital） | This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied) |
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 7 days | — |
| Incidence of major serious complications and serious arrhythmia | Up to 7 days after surgery（or leaving hospital） | — |
| Duration of postoperative delirium | Up to 7 days after surgery（or leaving hospital） | — |
| Incidence of postoperative hypoxia | Up to 1 day after surgery | — |
Countries
China
Contacts
Primary ContactDiansan Su, Doctor
Backup ContactZhenling Huang, Doctor
Outcome results
None listed