Delirium, Dexmedetomidine, Lower Extremity Problem, Propofol
Conditions
Brief summary
Delirium occurs commonly in elderly patients. Its incidence after orthopedic surgery has been reported to be 5-61%. Delirium is classified into three sub-types: Hypoactive, hyperactive, and mixed. Although hyperactive delirium is not as common as hypoactive delirium, the abnormal behavior pattern of hyperactive delirium, such as agitation, confusion, or aggressiveness, is considered to be harmful to patients and medical personnel. Thus, it is important to promptly manage such behaviors associated with hyperactive delirium. Intraoperative sedation plays an important role in relieving anxiety or stress response of patients. Propofol-a common sedative agent-was reported to cause delirium more frequently, compared with dexmedetomidine, in post-cardiac surgery patients or mechanically-ventilated patients in the intensive care unit (ICU). In addition to the benefits of reducing opioid consumption and postoperative nausea/vomiting, dexmedetomidine is most often used for ICU sedation or procedural sedation. However, there has not been any prospective randomized study investigating how intraoperative dexmedetomidine sedation during regional anesthesia affects postoperative consciousness, perception, memory, behavior, emotion, and so on. In this study, based on the hypothesis that intraoperative dexmedetomidine sedation may reduce the incidence of abnormal psycho-motor behavior compared with propofol sedation, investigators prospectively will investigate the incidence of postoperative delirium in elderly patients who undergo orthopedic surgery with regional anesthesia.
Interventions
DRUGPropofol
Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml.
DRUGDexmedetomidine
Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients who undergo orthopedic surgery under spinal anesthesia * Patients who want to sedation during the surgery * Age of 65 years or greater * American Society of Anesthesiologists physical status classification 1 and 2
Exclusion criteria
* General anesthesia * Age \< 65 years * Patients who do not want to sedation during the surgery * Patients who do not receive patient controlled analgesia postoperatively. * Cognitive disorders * Central nervous system disease, including dementia and Parkinson's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | Within 3 day postoperatively | The incidence of postoperative delirium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale | Postoperative 24 hour | Postoperative pain score |
| Patient controlled analgesia (PCA) | Postoperative 24 hour | Amounts of the PCA consumption |
| Rescue analgesics | Postoperative 24 hour | Amounts of the analgesics administered to manage the postoperative pain |
Countries
South Korea
Outcome results
None listed