Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409344
Status:
TERMINATED
Last Update Posted:
2009-09-22
First Post:
2006-12-07
Brief Title:
Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase 4 Study of Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms
Status:
TERMINATED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Surgical approach changed therefore subject enrollment not possible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 138 renal 135 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 proceduresOther 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
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 proceduresOther 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND74068 | None | None | None |