Dexmedetomidine and Delirium in Elderly Patients

NCT ID: NCT03938831

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-08-28

Brief Summary

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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

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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.

Conditions

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Delirium, Dexmedetomidine, Postoperative PCA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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dexmedetomidine group

dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Intervention Type DRUG

Fentanyl-based PCA infusion

control group

Fentanyl-based PCA infusion for 2 days

Group Type PLACEBO_COMPARATOR

Fentanyl-based PCA infusion

Intervention Type DRUG

Fentanyl-based PCA infusion

Interventions

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Dexmedetomidine

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

Fentanyl-based PCA infusion

Fentanyl-based PCA infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Il Ok Lee

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Il-Ok Lee, professor

Role: STUDY_CHAIR

Korea University Guro Hospital

Locations

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KoreaUniversity Guro Hospital

Seoul, Guro-ku, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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K2019-03 58-003

Identifier Type: -

Identifier Source: org_study_id

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