Dexmedetomidine and Delirium in Elderly Patients

Sponsor

Korea University Guro Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03938831

Collaborator

(none)

Enrollment

Location

Arms

39.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium, Dexmedetomidine, Postoperative PCA	Drug: Dexmedetomidine Drug: Fentanyl-based PCA infusion	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlrandomized control

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery

Actual Study Start Date :

May 1, 2019

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Aug 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dexmedetomidine group dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days	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 Drug: Fentanyl-based PCA infusion Fentanyl-based PCA infusion
Placebo Comparator: control group Fentanyl-based PCA infusion for 2 days	Drug: Fentanyl-based PCA infusion Fentanyl-based PCA infusion

Arm

Intervention/Treatment

Experimental: dexmedetomidine group

dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days

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

Drug: Fentanyl-based PCA infusion

Fentanyl-based PCA infusion

Placebo Comparator: control group

Fentanyl-based PCA infusion for 2 days

Drug: Fentanyl-based PCA infusion

Fentanyl-based PCA infusion

Outcome Measures

Primary Outcome Measures

delirium [2 days]
reduction of incidence of delirium

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KoreaUniversity Guro Hospital	Seoul	Guro-ku	Korea, Republic of	08308

Sponsors and Collaborators

Korea University Guro Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Il Ok Lee, professor, Korea University Guro Hospital

ClinicalTrials.gov Identifier:

NCT03938831

Other Study ID Numbers:

K2019-03 58-003

First Posted:

May 6, 2019

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Fentanyl

Dexmedetomidine

Study Results

No Results Posted as of Mar 31, 2022