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Trial record 2 of 2 for:    Dexmedetomidine and Cognitive Reserve

Perioperative Cognitive Function - Dexmedetomidine and Cognitive Reserve

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00561678
First Posted: November 21, 2007
Last Update Posted: March 29, 2017
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.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Stacie Deiner, Icahn School of Medicine at Mount Sinai
Results First Submitted: February 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Postoperative Delirium
PD
Postoperative Cognitive Dysfunction
POCD
Interventions: Drug: Precedex (Dexmedetomidine)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Precedex Precedex (Dexmedetomidine) 0.5/ug/kg/hr
Placebo Placebo - normal saline 0.5/ug/kg/hr

Participant Flow:   Overall Study
    Precedex   Placebo
STARTED   197   207 
COMPLETED   189   201 
NOT COMPLETED   8   6 
Withdrawal by Subject                4                3 
surgery cancelled                1                1 
surgery rescheduled to different site                2                2 
anesthesia provider refusal                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Precedex Precedex (Dexmedetomidine) 0.5/ug/kg/hr
Placebo Placebo - normal saline 0.5/ug/kg/hr
Total Total of all reporting groups

Baseline Measures
   Precedex   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 189   201   390 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 74.0 
 (71.0 to 78.0) 
 74.0 
 (71.0 to 78.0) 
 74.0 
 (71.0 to 78.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      97  51.3%      103  51.2%      200  51.3% 
Male      92  48.7%      98  48.8%      190  48.7% 
Education 
[Units: Years]
Median (Inter-Quartile Range)
 16.0 
 (12.0 to 18.0) 
 15.0 
 (12.0 to 17.0) 
 16.0 
 (12.0 to 18.0) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 28.1 
 (24.3 to 31.7) 
 27.7 
 (24.0 to 32.3) 
 28.0 
 (24.1 to 31.9) 
Anesthesia Time 
[Units: Minutes]
Median (Inter-Quartile Range)
 252.0 
 (173.0 to 348.0) 
 254.0 
 (191.0 to 339.0) 
 253.0 
 (185.0 to 345.0) 
Surgical Time 
[Units: Minutes]
Median (Inter-Quartile Range)
 174.0 
 (119.0 to 233.0) 
 180.0 
 (123.0 to 249.0) 
 177.0 
 (121.0 to 238.0) 
Mild Cognitive Impairment (MCI) 
[Units: Participants]
Count of Participants
 124   122   246 
ASA Status [1] 
[Units: Participants]
Count of Participants
     
1 or 2   73   63   136 
 108   133   241 
 8   5   13 
[1]

The American Society of Anesthesiologists (ASA) Physical Status classification:

  1. - normal healthy patient
  2. - patients with mild systemic disease
  3. - patients with severe systemic disease
  4. - patients with severe systemic disease that is a constant threat to life
Coronary Artery Disease (CAD) 
[Units: Participants]
Count of Participants
 14   18   32 
Hypertension (HTN) 
[Units: Participants]
Count of Participants
 124   116   240 
Congestive Heart Failure (CHF) 
[Units: Participants]
Count of Participants
 0   1   1 
Diabetes (DM) 
[Units: Participants]
Count of Participants
 39   40   79 
Cancer (CA) 
[Units: Participants]
Count of Participants
 81   77   158 
Surgical Procedure 
[Units: Participants]
Count of Participants
     
Spine   70   77   147 
Thoracic   5   6   11 
Orthopedic   54   36   90 
Urologic   20   29   49 
General   40   53   93 
Fentanyl 
[Units: µg/h]
Median (Inter-Quartile Range)
 250.0 
 (150.0 to 350.0) 
 250.0 
 (200.0 to 400.0) 
 250.0 
 (175.0 to 375.0) 
Propofol 
[Units: Mg/kg]
Median (Inter-Quartile Range)
 170.0 
 (120.0 to 360.0) 
 160.0 
 (120.0 to 220.0) 
 165.0 
 (120.0 to 300.0) 


  Outcome Measures
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1.  Primary:   Delirium Battery   [ Time Frame: post surgery ]

2.  Secondary:   Neuropsychological Testing   [ Time Frame: at 3 months postoperatively ]

3.  Secondary:   Intraoperative Bradycardia   [ Time Frame: day 1 ]

4.  Secondary:   Intraoperative Hypotension   [ Time Frame: day 1 ]

5.  Secondary:   Intraoperative Hypertension   [ Time Frame: day 1 ]

6.  Secondary:   Length of Stay   [ Time Frame: average 4 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Stacie Deiner
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-7749
e-mail: stacie.deiner@mountsinai.org



Responsible Party: Stacie Deiner, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00561678     History of Changes
Other Study ID Numbers: GCO 06-0217
1R01AG029656-01A1 ( U.S. NIH Grant/Contract )
First Submitted: November 19, 2007
First Posted: November 21, 2007
Results First Submitted: February 10, 2017
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017