Dexmedetomidine and Delirium in Elderly Patients

Delirium, Dexmedetomidine, Postoperative PCA Clinical Trial

Official title:

Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03938831
• Other study ID #: K2019-03 58-003
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: August 28, 2022

Study information

• Verified date: March 2022
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: August 28, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium, Dexmedetomidine, Postoperative PCA

Intervention

Drug:
• 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
• Fentanyl-based PCA infusion
Fentanyl-based PCA infusion

Locations

Country	Name	City	State
Korea, Republic of	KoreaUniversity Guro Hospital	Seoul	Guro-ku

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delirium	reduction of incidence of delirium	2 days