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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00409344 |
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 |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ulrich Schmidt, MD, PhD | 617-724-6490 | uschmidt@partners.org |
Contact: Houman Amirfarzan, MD | 617-724-2247 | hamirfarzan@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Ulrich Schmidt, MD,PhD | Massachusetts General Hospital |
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 |
Thoracoabdominal Aortic Aneurysm Dexmedetomidine Mechanical ventilation |
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 |
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 |