- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03938831
Dexmedetomidine and Delirium in Elderly Patients
Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guro-ku
-
Seoul, Guro-ku, Korea, Republic of, 08308
- KoreaUniversity Guro Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: dexmedetomidine group
dexmedetomidine mixture with fentanyl-based PCA infusion for 2 days
|
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
|
PLACEBO_COMPARATOR: control group
Fentanyl-based PCA infusion for 2 days
|
Fentanyl-based PCA infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
delirium
Time Frame: 2 days
|
reduction of incidence of delirium
|
2 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Il-Ok Lee, professor, Korea University Guro Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Fentanyl
- Dexmedetomidine
Other Study ID Numbers
- K2019-03 58-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium, Dexmedetomidine, Postoperative PCA
-
Beni-Suef UniversityRecruitingChildren | Dexmedetomidine | Morphine | PCAEgypt
-
Boston Intelligent Medical Research Center, Shenzhen...Zhongshan Hospital Of Traditional Chinese MedicineRecruitingPostoperative Delirium | General Anesthesia | DexmedetomidineChina
-
Beijing Tiantan HospitalRecruitingPostoperative Delirium | DexmedetomidineChina
-
Beijing Tiantan HospitalRecruitingPostoperative Delirium | Dexmedetomidine | Propofol | Brain Network ConnectivityChina
-
Beijing Tiantan HospitalCompletedPostoperative Delirium | DexmedetomidineChina
-
Peking University First HospitalBeijing Jishuitan HospitalActive, not recruitingAnalgesia | Postoperative Delirium | Elderly | Orthopedic Surgery | Dexmedetomidine | Long-term OutcomeChina
-
Peking University First HospitalBeijing Jishuitan HospitalSuspendedPostoperative Delirium | Elderly | Knee Arthroplasty | Dexmedetomidine | Long-term Outcome | Nerve BlockChina
-
Sunnybrook Health Sciences CentreActive, not recruitingDepression | Delirium | Cognitive Impairment | Postoperative Cognitive Dysfunction | DexmedetomidineCanada
-
Peking University First HospitalPeking University International Hospital; Affiliated Hospital of Hebei University and other collaboratorsCompletedDelirium | Analgesia | Surgery | Elderly | Dexmedetomidine | Complication, PostoperativeChina
-
Diskapi Yildirim Beyazit Education and Research...UnknownPostoperative Pain, PCA Contramal Consumption
Clinical Trials on Dexmedetomidine
-
Cairo UniversityUnknownSpinal Anesthesia DurationEgypt
-
Guangzhou Women and Children's Medical CenterCompletedAmbulatory Surgical ProceduresChina
-
The First Affiliated Hospital with Nanjing Medical...CompletedPostoperative Pain | Breast Feeding | Analgesia ObstetricalChina
-
Seoul National University Bundang HospitalCompleted
-
Guangzhou General Hospital of Guangzhou Military...CompletedPharmacodynamic InteractionChina
-
University Hospital DubravaRecruitingAortic Valve Stenosis | Systemic Inflammatory ResponseCroatia
-
Guangzhou General Hospital of Guangzhou Military...Completed
-
First Affiliated Hospital, Sun Yat-Sen UniversityUnknownArteriovenous MalformationChina
-
Guangzhou General Hospital of Guangzhou Military...UnknownCombined Spinal-epidural AnesthesiaChina
-
Eye & ENT Hospital of Fudan UniversityCompletedAgitated; State, Acute Reaction to StressChina