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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.
 
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

Tracking Information
First Submitted Date  ICMJE December 7, 2006
First Posted Date  ICMJE December 8, 2006
Results First Submitted Date  ICMJE February 26, 2009
Results First Posted Date  ICMJE September 16, 2009
Last Update Posted Date September 22, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
  • Time to a Successful Spontaneous Breathing Trial. [ Time Frame: 1/1/2008 ]
    Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.
  • Intensive Care Unit Length of Stay [ Time Frame: 1/1/2008 ]
    The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2006)
Primary outcomes: Time to a successful spontaneous breathing trial, ICU length of stay
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2009)
  • Secondary Endpoints Include:Amount of Sedative and Opiates Given [ Time Frame: 1/1/2008 ]
    Did not achieve this outcome due to no enrollment of participants
  • Time to Extubation [ Time Frame: 1/1/2008 ]
    Did not achieve this outcome due to no enrollment of participants
  • Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability [ Time Frame: 1/1/2008 ]
    Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome
  • Pharmaco-economics [ Time Frame: 1/1/2008 ]
    Did not achieve this outcome due to no enrollment of participants
  • Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed [ Time Frame: 1/1/2008 ]
    Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2006)
  • Secondary endpoints include:
  • Time to Extubation
  • Amount of sedative and opiates given
  • Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability
  • Pharmaco-economics
  • Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms
Official Title  ICMJE Phase 4 Study of Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms
Brief Summary The primary objective of this study is to test the hypothesis that time on the ventilator and ICU length of stay will be shorter in TAA patients given postoperative sedation with dexmedetomidine compared to those given standard sedation. Secondary endpoints are: requirement for sedatives vasoactive drugs incidence of postoperative delirium and cost analysis.
Detailed Description

Repair of thoraco-abdominal aortic aneurysms (TAA) is mostly performed in specialized centers. These centers report an operative mortality around 10%. In an analysis of 337 consecutive TAA, Cambria et al reported pulmonary (44%), cardiac, (13.8 %) renal (13.5%) and postoperative spinal cord deficit as prominent complications. Due to the extent of the surgery and the high risk of complications, all these patients require post- operative care in the Intensive Care Unit (ICU). In 2003, the operation was performed in approximately 40 patients at the Massachusetts General Hospital (MGH). The median length of stay in the ICU was 7 days (range 2-55) All patients required postoperative mechanical ventilation for greater than 48 h. During this period, a continuous intravenous infusion of propofol is normally used for sedation. Pain relief is provided by a continuous intravenous infusion of hydromorphone. This combination of sedation and analgesia is widely used at MGH and other institutions. Although very effective, it may cause respiratory depression and a deep sedative state, which may result in a prolonged requirement for mechanical ventilation. Lighter or more controllable sedation appears to be beneficial in this regard: daily wake up of intubated and sedated ICU patients decreases days on the ventilator and length of stay in the ICU.

Dexmedetomidine is a highly specific α2 agonist with prominent central nervous system (CNS) and cardiovascular effects It is FDA-approved as a postoperative sedative-hypnotic agent for intensive care patients for use up to 24 hours. The drug has hypnotic, sedative, analgesic and anxiolytic actions, and it tends to cause a mild decrease in blood pressure and heart rate. Patients or healthy volunteers sedated with dexmedetomidine alone are easily arousable and have no apparent respiratory depression. Dexmedetomidine has synergistic hypnotic and analgesic interactions with virtually all CNS depressants tested. It significantly decreases sedative and opioid requirements during and after major surgical procedures.Other potentially beneficial effects that are not as well-documented include bronchodilation and the ability to induce a more 'physiologic' sleep than other hypnotics commonly used in the ICU. Dexmedetomidine sedation may also be associated with a lower incidence of delirium.

Patients recovering from TAA surgery routinely require substantial ICU resources. If dexmedetomidine decreases the opioid and sedative requirement in these patients, it may potentially decrease the average number of days spent on the ventilator and in the ICU.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Sedation
  • Respiration, Artificial
  • Length of Stay
Intervention  ICMJE
  • Drug: Dexmedetomidine
    A continuous infusion of dexmedetomidine will be started at a dose of 0.8mcg/kg/hr. This will continue for no longer than 24 hours. Four hours post extubation the study drug wii be discontinued using a standard tapering protocol: 0.6mcg/kg/hr for 4 hours then 0.4mcg/kg/hr for 4 hours, then 0.2 mcg/kg/hr for 4 hours and then 0.1mcg/kg/hr for 4 hours and then turned off.
    Other Name: No other names have been specified
  • Other: Normal Saline
    Normal Saline will be given as the placebo and will administered at 0.8mcg/kg/hr
    Other Name: No other names have been specified
Study Arms  ICMJE
  • Placebo Comparator: 1
    Normal Saline
    Intervention: Other: Normal Saline
  • Active Comparator: Dexmedetomidine
    Dexmedetomidine is a highly specific a2 agonist with prominent central nervous system and cardiovascular effects. A postoperative sedative-hypnotic agent for intensive care patients for use up to 24 hours.
    Interventions:
    • Drug: Dexmedetomidine
    • Other: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2009)
0
Original Enrollment  ICMJE
 (submitted: December 7, 2006)
30
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All Patients over age 18 undergoing non-emergent repair of type I-III TAA

Exclusion Criteria:

  • Pregnancy
  • Patients with hepatic impairment (increase of ALT or AST three times normal)
  • Patient taking clonidine or tricyclic antidepressants.
  • Patients taking opioids or benzodiazepines chronically (> 2 doses a day for > 1 month)
  • Patients with second or third degree heart block without a pacer
  • Patients undergoing emergency repair of TAA
  • Intraoperative cardiac arrest
  • Intraoperative massive blood loss (>10 l)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00409344
Other Study ID Numbers  ICMJE 2006-P-001827
IND:74068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ulrich Schmidt, MD PhD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Ulrich Schmidt, MD,PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP