Dexmedetomidine and Delirium in Elderly Patients

Not Applicable

• Conditions: Delirium, Dexmedetomidine, Postoperative PCA
• Interventions: Drug: Dexmedetomidine; Drug: Fentanyl-based PCA infusion

• Registration Number: NCT03938831
• Lead Sponsor: Korea University Guro Hospital

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.

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-04-30
• Study Completion: 2022-08-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

over 65 yrs old elderly patient who undergo elective hip surgery and ASA(The American Society of Anesthesiologists) physical status I-III

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	Fentanyl-based PCA infusion	dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days
control group	Fentanyl-based PCA infusion	Fentanyl-based PCA infusion for 2 days
dexmedetomidine group	Dexmedetomidine	dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days

Primary Outcome Measures

Name	Time	Method
delirium	2 days	reduction of incidence of delirium

Trial Locations

Locations (1)

KoreaUniversity Guro Hospital; 🇰🇷 Seoul, Guro-ku, Korea, Republic of