Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

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. Identifier: NCT00409344
Recruitment Status : Terminated (Surgical approach changed therefore subject enrollment not possible.)
First Posted : December 8, 2006
Results First Posted : September 16, 2009
Last Update Posted : September 22, 2009
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by:
Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions: Sedation
Respiration, Artificial
Length of Stay
Interventions: Drug: Dexmedetomidine
Other: Normal Saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period 10/10/2006 to 1/1/2008 from a surgical intensive care unit in a tertiary hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Unable to enroll participants due to hepatic impairment and many patients taking tricyclic antidepressants.

Reporting Groups
Saline This group will recive saline
Dexmedetomidine This group will receive dexmedetomidine

Participant Flow:   Overall Study
    Saline   Dexmedetomidine
STARTED   0 [1]   0 [1] 
COMPLETED   0 [2]   0 [2] 
no enrollment                0                0 
[1] No participants enrolled
[2] No participants were enrolled to completion

  Baseline Characteristics

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
Saline This group will recive saline
Dexmedetomidine This group will receive dexmedetomidine
Total Total of all reporting groups

Baseline Measures
   Saline   Dexmedetomidine   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Participants]
Female   0   0   0 
Male   0   0   0 

  Outcome Measures

1.  Primary:   Time to a Successful Spontaneous Breathing Trial.   [ Time Frame: 1/1/2008 ]

2.  Primary:   Intensive Care Unit Length of Stay   [ Time Frame: 1/1/2008 ]

3.  Secondary:   Secondary Endpoints Include:Amount of Sedative and Opiates Given   [ Time Frame: 1/1/2008 ]

4.  Secondary:   Time to Extubation   [ Time Frame: 1/1/2008 ]

5.  Secondary:   Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability   [ Time Frame: 1/1/2008 ]

6.  Secondary:   Pharmaco-economics   [ Time Frame: 1/1/2008 ]

7.  Secondary:   Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed   [ Time Frame: 1/1/2008 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
Unable to enroll participants into the study

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Ulrich Schmidt, MD PhD
Organization: Massachusetts General Hospital
phone: 617-724-6490

Responsible Party: Ulrich Schmidt, MD PhD, Massachusetts General Hospital Identifier: NCT00409344     History of Changes
Other Study ID Numbers: 2006-P-001827
First Submitted: December 7, 2006
First Posted: December 8, 2006
Results First Submitted: February 26, 2009
Results First Posted: September 16, 2009
Last Update Posted: September 22, 2009