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Clinical Trials/NCT03938831
NCT03938831
Unknown
Not Applicable

Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery

Korea University Guro Hospital1 site in 1 country60 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Delirium, Dexmedetomidine, Postoperative PCA
Sponsor
Korea University Guro Hospital
Enrollment
60
Locations
1
Primary Endpoint
delirium
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
August 28, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Il Ok Lee

professor

Korea University Guro Hospital

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

Arms & Interventions

dexmedetomidine group

dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days

Intervention: Dexmedetomidine

dexmedetomidine group

dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days

Intervention: Fentanyl-based PCA infusion

control group

Fentanyl-based PCA infusion for 2 days

Intervention: Fentanyl-based PCA infusion

Outcomes

Primary Outcomes

delirium

Time Frame: 2 days

reduction of incidence of delirium

Study Sites (1)

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