Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398827
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2006-11-10
Brief Title:
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care MAC
Sponsor:
Hospira now a wholly owned subsidiary of Pfizer
Organization:
Hospira now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care MAC
Detailed Description:
Monitored anesthesia care MAC is a specific anesthesia service that involves an anesthesiologist administering sedatives and analgesics to a patient while monitoring hisher vital signs MAC is often used to supplement local and regional anesthesia for non-intubated patients undergoing non-invasive procedures and minor surgery The goal of MAC is to relieve anxiety by inducing a minimally depressed level of consciousness while the patient is able to continuously and independently maintain a patent airway and to respond appropriately to verbal commands
Respiratory depression is the major concern with most of the medications midazolam fentanyl propofol currently used for MAC There is clearly an unmet need for a sedative agent that can safely be used during MAC in both healthy and high risk populations with limited adverse side effects A medication that can attenuate anxiety and the stress response associated with surgery and procedures without causing respiratory depression is highly desirable A medication that reduces the total amount of opioids administered during a procedure could substantially reduce complications Such a medication could be used either alone or in combination with other agents thereby reducing the dose and side effects of the other agents
Dexmedetomidine DEX has sympatholytic sedative analgesic and anxiolytic effects that attenuate the catecholamine response to perioperative stress DEX has not been associated with respiratory depression when used alone despite sometimes deep levels of sedation
An estimated 325 patients 260 DEX 65 PBO requiring MAC sedation for an elective surgeryprocedure will be randomized at approximately 25 investigative sites
Respiratory depression is the major concern with most of the medications midazolam fentanyl propofol currently used for MAC There is clearly an unmet need for a sedative agent that can safely be used during MAC in both healthy and high risk populations with limited adverse side effects A medication that can attenuate anxiety and the stress response associated with surgery and procedures without causing respiratory depression is highly desirable A medication that reduces the total amount of opioids administered during a procedure could substantially reduce complications Such a medication could be used either alone or in combination with other agents thereby reducing the dose and side effects of the other agents
Dexmedetomidine DEX has sympatholytic sedative analgesic and anxiolytic effects that attenuate the catecholamine response to perioperative stress DEX has not been associated with respiratory depression when used alone despite sometimes deep levels of sedation
An estimated 325 patients 260 DEX 65 PBO requiring MAC sedation for an elective surgeryprocedure will be randomized at approximately 25 investigative sites
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