Intraoperative Sedatives and Postoperative Deilirium

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lower Extremity Problem, Delirium, Propofol, Dexmedetomidine

Intervention / Treatment
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* Drug: Propofol
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPF<br>Patient who received propofol during the operation | Drug: Propofol<br>* 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.<br>|
| Experimental: DEX<br>Patient who received dexmedetomidine during the operation | Drug: Dexmedetomidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | The incidence of postoperative delirium | Within 3 day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale | Postoperative pain score | Postoperative 24 hour | 
| Numerical rating scale | Postoperative pain score | Postoperative 48 hour | 
| Numerical rating scale | Postoperative pain score | Postoperative 72 hour | 
| Patient controlled analgesia (PCA) | Amounts of the PCA consumption | Postoperative 24 hour | 
| Patient controlled analgesia (PCA) | Amounts of the PCA consumption | Postoperative 48 hour | 
| Patient controlled analgesia (PCA) | Amounts of the PCA consumption | Postoperative 72 hour | 
| Rescue analgesics | Amounts of the analgesics administered to manage the postoperative pain | Postoperative 24 hour | 
| Rescue analgesics | Amounts of the analgesics administered to manage the postoperative pain | postoperative 48 hour | 
| Rescue analgesics | Amounts of the analgesics administered to manage the postoperative pain | Postoperative 72 hour |