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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

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.

Condition or disease Intervention/treatment Phase
Sedation Respiration, Artificial Length of Stay Drug: Dexmedetomidine Other: Normal Saline Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms
Study Start Date : January 2007
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Normal Saline
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
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.
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



Primary Outcome Measures :
  1. Time to a Successful Spontaneous Breathing Trial. [ Time Frame: 1/1/2008 ]
  2. Intensive Care Unit Length of Stay [ Time Frame: 1/1/2008 ]

Secondary Outcome Measures :
  1. Secondary Endpoints Include:Amount of Sedative and Opiates Given [ Time Frame: 1/1/2008 ]
  2. Time to Extubation [ Time Frame: 1/1/2008 ]
  3. Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability [ Time Frame: 1/1/2008 ]
  4. Pharmaco-economics [ Time Frame: 1/1/2008 ]
  5. Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed [ Time Frame: 1/1/2008 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409344


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Ulrich Schmidt, MD,PhD Massachusetts General Hospital

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 Posted: December 8, 2006    Key Record Dates
Results First Posted: September 16, 2009
Last Update Posted: September 22, 2009
Last Verified: September 2009

Keywords provided by Massachusetts General Hospital:
Thoracoabdominal Aortic Aneurysm
Dexmedetomidine
Mechanical ventilation

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action