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Dexmedetomidine and Delirium in Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03938831
Recruitment Status : Unknown
Verified August 2019 by Il Ok Lee, Korea University Guro Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Il Ok Lee, Korea University Guro Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized 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
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arms and Interventions
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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
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Primary Outcome Measures :
  1. delirium [ Time Frame: 2 days ]
    reduction of incidence of delirium


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938831


Locations
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Korea, Republic of
KoreaUniversity Guro Hospital
Seoul, Guro-ku, Korea, Republic of, 08308
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
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Study Chair: Il-Ok Lee, professor Korea University Guro Hospital
More Information
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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    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Fentanyl
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics