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Clinical Trials/NCT03251651
NCT03251651
Completed
N/A

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

Seoul National University Bundang Hospital1 site in 1 country748 target enrollmentJune 15, 2017

Overview

Phase
N/A
Intervention
Propofol
Conditions
Lower Extremity Problem
Sponsor
Seoul National University Bundang Hospital
Enrollment
748
Locations
1
Primary Endpoint
Postoperative delirium
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2017
End Date
October 15, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyo-Seok Na

Associate Professor

Seoul National University Bundang Hospital

Eligibility Criteria

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

Arms & Interventions

PPF

Patient who received propofol during the operation

Intervention: Propofol

DEX

Patient who received dexmedetomidine during the operation

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

Postoperative delirium

Time Frame: Within 3 day postoperatively

The incidence of postoperative delirium

Secondary Outcomes

  • Numerical rating scale(Postoperative 72 hour)
  • Patient controlled analgesia (PCA)(Postoperative 72 hour)
  • Rescue analgesics(Postoperative 72 hour)

Study Sites (1)

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