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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
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium, Dexmedetomidine, Postoperative PCA

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 3, 2019
Last Updated
March 29, 2022
Sponsor
Korea University Guro Hospital
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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

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Dexmedetomidine and Delirium in Elderly Patients

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