Dexmedetomidine and Delirium in Elderly Patients
Primary Purpose
Delirium, Dexmedetomidine, Postoperative PCA
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
Fentanyl-based PCA infusion
Sponsored by
About this trial
This is an interventional prevention trial for Delirium, Dexmedetomidine, Postoperative PCA
Eligibility Criteria
Inclusion Criteria: over 65 yrs old elderly patient who undergo elective hip surgery and ASA(The American Society of Anesthesiologists) physical status I-III
Exclusion Criteria:
history of dementia, drug abuser, hypersensitivity to dexmedetomidine, fentanyl, propofol, disable to speech, reject the clinical study, hemodynamic instability during surgery, an illiterate, pregnancy
Sites / Locations
- KoreaUniversity Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dexmedetomidine group
control group
Arm Description
dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days
Fentanyl-based PCA infusion for 2 days
Outcomes
Primary Outcome Measures
delirium
reduction of incidence of delirium
Secondary Outcome Measures
Full Information
NCT ID
NCT03938831
First Posted
May 3, 2019
Last Updated
March 29, 2022
Sponsor
Korea University Guro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03938831
Brief Title
Dexmedetomidine and Delirium in Elderly Patients
Official Title
Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
August 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators investigates the effect of perioperative dexmedetomidine 0.5 ug/kg/hr followed by a postoperative continuous infusion fentanyl-based PCA(Patient-Controlled Analgesia) drug mixed with dexmedetomidine 0.2ug/kg/hr for two days on reducing postoperative delirium and postoperative rescue analgesics in elderly patients who undergo hip surgery. The other half of patients received fentanyl-based PCA only.
Detailed Description
Elderly patients are susceptible to postoperative delirium. Delirium occurs in 10~60% and is associated with longer hospital stays, increased costs, and morbidity. Postoperative delirium usually occurs 2~3 days after surgery. Intraoperative infusion of dexmedetomidine lacks preventing postoperative delirium in elderly noncardiac major surgery.
We hypothesized postoperative dexmedetomidine for two days as a mixture drug of fentanyl-based PCA could reduce the incidence of postoperative delirium. We compared this effect with other control group who received fentanyl-based PCA only.
We also investigate EEG patterns of patients during emergence and compared the EEG patterns who developed delirium postoperatively in PACU(Postanesthesia care unit) or general ward. Dexmedetomidine has analgesic effect. We expected postoperative dexmedetomidine has benefits of opioid sparing effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Dexmedetomidine, Postoperative PCA
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine group
Arm Type
Experimental
Arm Description
dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Fentanyl-based PCA infusion for 2 days
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
dexmedetomidine 0.5 micg/kg/hr infusion during operation and followed by 0.2 mic/kg/hr with fentanyl-based PCA mixture for 2 days
Intervention Type
Drug
Intervention Name(s)
Fentanyl-based PCA infusion
Intervention Description
Fentanyl-based PCA infusion
Primary Outcome Measure Information:
Title
delirium
Description
reduction of incidence of delirium
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 65 yrs old elderly patient who undergo elective hip surgery and ASA(The American Society of Anesthesiologists) physical status I-III
Exclusion Criteria:
history of dementia, drug abuser, hypersensitivity to dexmedetomidine, fentanyl, propofol, disable to speech, reject the clinical study, hemodynamic instability during surgery, an illiterate, pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Il-Ok Lee, professor
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
KoreaUniversity Guro Hospital
City
Seoul
State/Province
Guro-ku
ZIP/Postal Code
08308
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine and Delirium in Elderly Patients
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