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Trial record 2 of 6 for:    "Aortic Disease" | "Analgesics, Non-Narcotic"

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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
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
Enrollment 0
Recruitment Details Recruitment period 10/10/2006 to 1/1/2008 from a surgical intensive care unit in a tertiary hospital.
Pre-assignment Details Unable to enroll participants due to hepatic impairment and many patients taking tricyclic antidepressants.
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description This group will recive saline This group will receive dexmedetomidine
Period Title: Overall Study
Started 0 [1] 0 [1]
Completed 0 [2] 0 [2]
Not Completed 0 0
Reason Not Completed
no enrollment             0             0
[1]
No participants enrolled
[2]
No participants were enrolled to completion
Arm/Group Title Saline Dexmedetomidine Total
Hide Arm/Group Description This group will recive saline This group will receive dexmedetomidine Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
<=18 years 0 0 0
Between 18 and 65 years 0 0 0
>=65 years 0 0 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
Female 0 0 0
Male 0 0 0
1.Primary Outcome
Title Time to a Successful Spontaneous Breathing Trial.
Hide Description Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.
Time Frame 1/1/2008
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description:
This group will recive saline
This group will receive dexmedetomidine
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Intensive Care Unit Length of Stay
Hide Description The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.
Time Frame 1/1/2008
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description:
This group will recive saline
This group will receive dexmedetomidine
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Secondary Endpoints Include:Amount of Sedative and Opiates Given
Hide Description Did not achieve this outcome due to no enrollment of participants
Time Frame 1/1/2008
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description:
This group will recive saline
This group will receive dexmedetomidine
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Extubation
Hide Description Did not achieve this outcome due to no enrollment of participants
Time Frame 1/1/2008
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description:
This group will recive saline
This group will receive dexmedetomidine
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability
Hide Description Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome
Time Frame 1/1/2008
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description:
This group will recive saline
This group will receive dexmedetomidine
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Pharmaco-economics
Hide Description Did not achieve this outcome due to no enrollment of participants
Time Frame 1/1/2008
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description:
This group will recive saline
This group will receive dexmedetomidine
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed
Hide Description Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.
Time Frame 1/1/2008
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Dexmedetomidine
Hide Arm/Group Description:
This group will recive saline
This group will receive dexmedetomidine
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ulrich Schmidt, MD PhD
Organization: Massachusetts General Hospital
Phone: 617-724-6490
EMail: uschmidt@partners.org
Layout table for additonal information
Responsible Party: Ulrich Schmidt, MD PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00409344     History of Changes
Other Study ID Numbers: 2006-P-001827
IND:74068
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