Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Primary Purpose
Postoperative Delirium, PD, Postoperative Cognitive Dysfunction
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Precedex (Dexmedetomidine)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Delirium focused on measuring Postoperative delirium, PD, Postoperative cognitive dysfunction, POCD
Eligibility Criteria
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Functional Recovery
Functional Recovery
Secondary Outcome Measures
Cognitive Testing
Cognitive Testing
Cognitive Testing
Delirium Assessments
Delirium Assessments
Delirium Assessments
Delirium Assessments
Full Information
NCT ID
NCT00455143
First Posted
April 2, 2007
Last Updated
June 27, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT00455143
Brief Title
Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Official Title
Cognitive Protection - Dexmedetomidine and Cognitive Reserve
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Pilot study initiated to provide support data for main grant GCO 06-0217 funded. only baseline characteristic data collected. no results for this study.
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to evaluate the effect of dexmedetomidine in the prevention of delirium in non-cardiac surgical patients. The preliminary data regarding the effect of dexmedetomidine on delirium comes from a study underway at Stanford. We propose to randomize fifty patients into two different protocols, one using dexmedetomidine until PACU discharge (hip replacement) and the other using dexmedetomidine for 24 hours in a monitored setting.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium, PD, Postoperative Cognitive Dysfunction, POCD
Keywords
Postoperative delirium, PD, Postoperative cognitive dysfunction, POCD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Precedex (Dexmedetomidine)
Other Intervention Name(s)
Precedex, Dexmedetomidine
Intervention Description
Dexmedetomidine started prior to surgery and continued for 24 hours postoperatively. Patients will receive dexmedetomidine until discharge from the PACU.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo given prior to surgery and continued for 24 hours postoperatively
Primary Outcome Measure Information:
Title
Functional Recovery
Time Frame
3 months post surgery
Title
Functional Recovery
Time Frame
6 months post surgery
Secondary Outcome Measure Information:
Title
Cognitive Testing
Time Frame
prior to surgery
Title
Cognitive Testing
Time Frame
3 months post surgery
Title
Cognitive Testing
Time Frame
6 months post surgery
Title
Delirium Assessments
Time Frame
prior to surgery
Title
Delirium Assessments
Time Frame
duration of PACU stay, up to 4 days post-op
Title
Delirium Assessments
Time Frame
3 months post surgery
Title
Delirium Assessments
Time Frame
6 months post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Silverstein, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
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Cognitive Protection - Dexmedetomidine and Cognitive Reserve
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