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| ID | Type | Description | Link |
|---|---|---|---|
| IND:74068 |
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Surgical approach changed therefore subject enrollment not possible.
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| Name | Class |
|---|---|
| Hospira, now a wholly owned subsidiary of Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Normal Saline |
|
| Dexmedetomidine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to a Successful Spontaneous Breathing Trial. | Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome. | 1/1/2008 |
| Intensive Care Unit Length of Stay | The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats. | 1/1/2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints Include:Amount of Sedative and Opiates Given | Did not achieve this outcome due to no enrollment of participants | 1/1/2008 |
| Time to Extubation | Did not achieve this outcome due to no enrollment of participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Schmidt, MD,PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Unable to enroll participants due to hepatic impairment and many patients taking tricyclic antidepressants.
Recruitment period 10/10/2006 to 1/1/2008 from a surgical intensive care unit in a tertiary hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline | This group will recive saline |
| FG001 | Dexmedetomidine | This group will receive dexmedetomidine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline | This group will recive saline |
| BG001 | Dexmedetomidine | This group will receive dexmedetomidine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to a Successful Spontaneous Breathing Trial. | Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome. | Posted | Number | hours | 1/1/2008 |
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|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saline | This group will recive saline |
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Unable to enroll participants into the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulrich Schmidt, MD PhD | Massachusetts General Hospital | 617-724-6490 | uschmidt@partners.org |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| Normal Saline | Other | Normal Saline will be given as the placebo and will administered at 0.8mcg/kg/hr |
|
|
| 1/1/2008 |
| Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability | Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome | 1/1/2008 |
| Pharmaco-economics | Did not achieve this outcome due to no enrollment of participants | 1/1/2008 |
| Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed | Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome. | 1/1/2008 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Secondary Endpoints Include:Amount of Sedative and Opiates Given | Did not achieve this outcome due to no enrollment of participants | Posted | Number | milligram of sedative an opiate | 1/1/2008 |
|
|
| Secondary | Time to Extubation | Did not achieve this outcome due to no enrollment of participants | Posted | Number | hours | 1/1/2008 |
|
|
| Secondary | Amount of Vasoactive Substances Used to Achieve Hemodynamic Stability | Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome | Posted | Number | participants | 1/1/2008 |
|
|
| Secondary | Pharmaco-economics | Did not achieve this outcome due to no enrollment of participants | Posted | Number | participants | 1/1/2008 |
|
|
| Secondary | Incidence of Delirium; Number of Shifts During Which Delirium Was Diagnosed | Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome. | Posted | Number | participants | 1/1/2008 |
|
|
| Primary | Intensive Care Unit Length of Stay | The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats. | Posted | Number | Days | 1/1/2008 |
|
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| EG001 | Dexmedetomidine | This group will receive dexmedetomidine |
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| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |