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Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms
This study is not yet open for participant recruitment.
Verified by Massachusetts General Hospital, December 2006
First Received: December 7, 2006   No Changes Posted
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00409344
  Purpose

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 Intervention Phase
Sedation
Respiration, Artificial
Length of Stay
Drug: Dexmedetomidine
Phase IV

MedlinePlus related topics: Aneurysms Aortic Aneurysm
Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 4 Study of Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Primary outcomes: Time to a successful spontaneous breathing trial, ICU length of stay

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: March 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409344

Contacts
Contact: Ulrich Schmidt, MD, PhD 617-724-6490 uschmidt@partners.org
Contact: Houman Amirfarzan, MD 617-724-2247 hamirfarzan@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ulrich Schmidt, MD,PhD Massachusetts General Hospital
  More Information

No publications provided

Study ID Numbers: 2006-P-001827, IND:74068
Study First Received: December 7, 2006
Last Updated: December 7, 2006
ClinicalTrials.gov Identifier: NCT00409344     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Aneurysm
Aortic Aneurysm, Thoracic
Adrenergic Agents
Vascular Diseases
Central Nervous System Depressants
Adrenergic Agonists
Aortic Diseases
Analgesics, Non-Narcotic
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Peripheral Nervous System Agents
Aortic Aneurysm

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

ClinicalTrials.gov processed this record on May 07, 2009