Clinical trial NCT03251651: Intraoperative Sedatives and Postoperative Deilirium
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Problem
Delirium
Propofol
Dexmedetomidine
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 748
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Postoperative delirium
timeFrame: Within 3 day postoperatively
Secondary outcomes:
measure: Numerical rating scale
timeFrame: Postoperative 24 hour
measure: Numerical rating scale
timeFrame: Postoperative 48 hour
measure: Numerical rating scale
timeFrame: Postoperative 72 hour
measure: Patient controlled analgesia (PCA)
timeFrame: Postoperative 24 hour
measure: Patient controlled analgesia (PCA)
timeFrame: Postoperative 48 hour
measure: Patient controlled analgesia (PCA)
timeFrame: Postoperative 72 hour
measure: Rescue analgesics
timeFrame: Postoperative 24 hour
measure: Rescue analgesics
timeFrame: postoperative 48 hour
measure: Rescue analgesics
timeFrame: Postoperative 72 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: