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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
748
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.
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.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Postoperative delirium
The incidence of postoperative delirium
Time frame: Within 3 day postoperatively
Numerical rating scale
Postoperative pain score
Time frame: Postoperative 24 hour
Numerical rating scale
Postoperative pain score
Time frame: Postoperative 48 hour
Numerical rating scale
Postoperative pain score
Time frame: Postoperative 72 hour
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Time frame: Postoperative 24 hour
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Time frame: Postoperative 48 hour
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Time frame: Postoperative 72 hour
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Time frame: Postoperative 24 hour
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Time frame: postoperative 48 hour
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Time frame: Postoperative 72 hour
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