Dexmedetomidine and Delirium in Elderly Patients

March 29, 2022 updated by: Il Ok Lee, Korea University Guro Hospital

Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guro-ku
      • Seoul, Guro-ku, Korea, Republic of, 08308
        • KoreaUniversity Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: dexmedetomidine group
dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days
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
Fentanyl-based PCA infusion
PLACEBO_COMPARATOR: control group
Fentanyl-based PCA infusion for 2 days
Fentanyl-based PCA infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delirium
Time Frame: 2 days
reduction of incidence of delirium
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Il-Ok Lee, professor, Korea University Guro Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ANTICIPATED)

April 30, 2022

Study Completion (ANTICIPATED)

August 28, 2022

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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