- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00455143
Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Study Overview
Status
Intervention / Treatment
Detailed Description
Elderly patients who undergo anesthesia and non-cardiac surgery are subject to deterioration of brain function including the development of postoperative delirium (PD) and postoperative cognitive dysfunction (POCD). These disorders cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use relatively primitive approaches to preventing and treating PD and POCD. The proposed is a pilot study for an NIH grant which was recently submitted. This is a randomized controlled trial of perioperative dexmedetomidine to prevent PD and, potentially, POCD. Fifty patients will be enrolled at Mount Sinai with two different surgeries, either hip replacement or vascular bypass. The patients undergoing hip replacement will receive dexmedetomidine until discharge from the PACU. Vascular surgery patients who are transferred from the PACU to a monitored step-sown unit will continue dexmedetomidine for 24 hours.Participants will be screened for Mild Cognitive Impairment (MCI), and undergo preoperative cognitive testing. Unlike the parent trial, we will test for but will not select for patients with MCI. Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively. Follow up studies will include surveillance for delirium while in the hospital and cognitive testing at 3 months following surgery.
Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 65 years and older
- elective major hip replacement or peripheral vascular (major surgery is defined by a planned 2 day hospitalization)
- ASA physical status I-III
- capable and willing to consent
Exclusion Criteria:
- Cardiac surgery
- Intracranial Surgery
- Emergency Surgery
- Patients with severe visual or auditory disorder/handicaps
- Illiteracy
- Patients with clinically significant Parkinson's Disease
- Patients not expected to be able to complete the 3 month postoperative test
- Sick sinus syndrome without pacemaker
- Hypersensitivity to drug or class
- Current 2nd or 3rd degree AV block
- History of clinically significant bradycardia
- Contraindication to the use of an 2A-agonist
- Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, or dementia
- ASA physical status IV or V
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexmedetomidine
Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively.
Patients will receive dexmedetomidine until discharge from the PACU.
|
Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively.
Patients will receive dexmedetomidine until discharge from the PACU.
Other Names:
|
Placebo Comparator: Placebo
Participants will be randomized to either dexmedetomidine or placebo which will be started prior to surgery and continued for 24 hours postoperatively or until discharge from the PACU.
|
Matching placebo given prior to surgery and continued for 24 hours postoperatively
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional Recovery
Time Frame: 3 months post surgery
|
3 months post surgery
|
Functional Recovery
Time Frame: 6 months post surgery
|
6 months post surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive Testing
Time Frame: prior to surgery
|
prior to surgery
|
Cognitive Testing
Time Frame: 3 months post surgery
|
3 months post surgery
|
Cognitive Testing
Time Frame: 6 months post surgery
|
6 months post surgery
|
Delirium Assessments
Time Frame: prior to surgery
|
prior to surgery
|
Delirium Assessments
Time Frame: duration of PACU stay, up to 4 days post-op
|
duration of PACU stay, up to 4 days post-op
|
Delirium Assessments
Time Frame: 3 months post surgery
|
3 months post surgery
|
Delirium Assessments
Time Frame: 6 months post surgery
|
6 months post surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeff Silverstein, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Delirium
- Cognitive Dysfunction
- Postoperative Cognitive Complications
- 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
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- GCO 06-0453
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 Postoperative Delirium
-
Qin ZhangNational Natural Science Foundation of ChinaRecruiting
-
Qin ZhangNational Natural Science Foundation of ChinaRecruitingDelirium, PostoperativeChina
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
-
Konya City HospitalCompletedPREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUMTurkey
-
University of VirginiaNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingIdentify Postoperative Delirium Using Exhaled Gas PatternsUnited States
-
University Hospital, GhentCompletedPostoperative Pain | Postoperative DeliriumBelgium
-
Menoufia UniversityCompleted
-
Marmara UniversityActive, not recruitingPostoperative Delirium | Postoperative Nausea | Postoperative VomitingTurkey
-
Heart and Brain Research Group, GermanyRecruitingPostoperative Delirium | Postoperative Cognitive Dysfunction | Postoperative Cognitive DeclineGermany
-
West China HospitalRecruitingDelirium | Postoperative Cognitive DysfunctionChina
Clinical Trials on Precedex (Dexmedetomidine)
-
University of JordanCompleted
-
Massachusetts General HospitalNot yet recruiting
-
Tanta UniversityCompletedInjection Site IrritationSaudi Arabia
-
South Egypt Cancer InstituteUnknownBreast Cancer FemaleEgypt
-
Zagazig UniversityCompleted
-
Assiut UniversityCompletedPostoperative Pain
-
Assiut UniversityCompleted
-
Ain Shams UniversityNot yet recruiting
-
The University of Hong KongCompletedThird Molar Extraction
-
Zagazig UniversityCompletedAnesthesia Intubation ComplicationEgypt