Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
NCT Number: NCT03251651
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.
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Notify Me65 year–90 year
All sexes
Interventional
Not applicable
Seongnam-si, Gyeonggi-do, 13620, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 3 day postoperatively
The incidence of postoperative delirium
Time frame: Postoperative 24 hour
Postoperative pain score
Time frame: Postoperative 48 hour
Postoperative pain score
Time frame: Postoperative 72 hour
Postoperative pain score
Time frame: Postoperative 24 hour
Amounts of the PCA consumption
Time frame: Postoperative 48 hour
Amounts of the PCA consumption
Time frame: Postoperative 72 hour
Amounts of the PCA consumption
Time frame: Postoperative 24 hour
Amounts of the analgesics administered to manage the postoperative pain
Time frame: postoperative 48 hour
Amounts of the analgesics administered to manage the postoperative pain
Time frame: Postoperative 72 hour
Amounts of the analgesics administered to manage the postoperative pain
Seoul National University Bundang Hospital
Other
The Incidence of Postoperative Delirium According to the Different Intraoperative Sedatives, Dexmedetomidine vs. Propofol, in Elderly Patients Undergoing Orthopedic Lower Limb Surgery With Spinal Anesthesia: A Randomized Trial
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