Intraoperative Sedatives and Postoperative Deilirium
Primary Purpose
Lower Extremity Problem, Delirium, Propofol
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Lower Extremity Problem
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PPF
DEX
Arm Description
Patient who received propofol during the operation
Patient who received dexmedetomidine during the operation
Outcomes
Primary Outcome Measures
Postoperative delirium
The incidence of postoperative delirium
Secondary Outcome Measures
Numerical rating scale
Postoperative pain score
Numerical rating scale
Postoperative pain score
Numerical rating scale
Postoperative pain score
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Patient controlled analgesia (PCA)
Amounts of the PCA consumption
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Rescue analgesics
Amounts of the analgesics administered to manage the postoperative pain
Full Information
NCT ID
NCT03251651
First Posted
August 14, 2017
Last Updated
July 7, 2022
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03251651
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Problem, Delirium, Propofol, Dexmedetomidine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
748 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPF
Arm Type
Experimental
Arm Description
Patient who received propofol during the operation
Arm Title
DEX
Arm Type
Experimental
Arm Description
Patient who received dexmedetomidine during the operation
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative delirium
Description
The incidence of postoperative delirium
Time Frame
Within 3 day postoperatively
Secondary Outcome Measure Information:
Title
Numerical rating scale
Description
Postoperative pain score
Time Frame
Postoperative 24 hour
Title
Numerical rating scale
Description
Postoperative pain score
Time Frame
Postoperative 48 hour
Title
Numerical rating scale
Description
Postoperative pain score
Time Frame
Postoperative 72 hour
Title
Patient controlled analgesia (PCA)
Description
Amounts of the PCA consumption
Time Frame
Postoperative 24 hour
Title
Patient controlled analgesia (PCA)
Description
Amounts of the PCA consumption
Time Frame
Postoperative 48 hour
Title
Patient controlled analgesia (PCA)
Description
Amounts of the PCA consumption
Time Frame
Postoperative 72 hour
Title
Rescue analgesics
Description
Amounts of the analgesics administered to manage the postoperative pain
Time Frame
Postoperative 24 hour
Title
Rescue analgesics
Description
Amounts of the analgesics administered to manage the postoperative pain
Time Frame
postoperative 48 hour
Title
Rescue analgesics
Description
Amounts of the analgesics administered to manage the postoperative pain
Time Frame
Postoperative 72 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-Seok Na, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Intraoperative Sedatives and Postoperative Deilirium
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