Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421720
Status:
TERMINATED
Last Update Posted:
2018-04-03
First Post:
2007-01-11
Brief Title:
A Study Comparing Two AnalgesiaSedation Regimens RemifentanilPropofol Versus SufentanilPropofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Open-label Multicenter Parallel-group Study to Compare the Efficacy Safety and Resource Utilization of a RemifentanilPropofol AnalgesiaSedation Regimen Versus a SufentanilPropofol AnalgesiaSedation Regimen in Mechanically Ventilated Intensive Care Patients Requiring Analgesia and Sedation for up to 7 Days
Status:
TERMINATED
Status Verified Date:
2018-03
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:
This prospective randomized multicenter open-label study will compare two analgesia-based regimens for sedation remifentanilpropofol vs sufentanilpropofol in medium to long-term ventilated intensive care patients in terms of efficacy safety and resource utilization
The special characteristics of intensive care patients organ insufficiencies etc regularly cause an accumulation of the analgesics sedatives and adjuvants used Clinically this complicates the calculation of weaning and extubation times often making mechanical ventilation necessary for longer periods than desired and also extending the stay of patients in the intensive care unit Reducing weaning times and the duration of intensive care treatment by optimizing analgesiasedation could furthermore lead to a reduction in typical complications such as ventilator-associated pneumonia or delirium
The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary depression and rapid onset of effect and in particular a short dura-tion of effect and absence of accumulation or development of active metabolites Remifentanil is an ultra-short acting µ-agonist which is due to its molecular structure metabolized organ-independently by unspecific blood and tissue esterases with the substance being degraded within only a few minutes and the resulting metabolites being virtually ineffective at the µ-receptor Sufentanil on the other hand is mainly metabolized by the cytochrome P-450-3A4 enzyme in the liver and small intestine
To date only one study with a small sample size is available on the comparison of the effectiveness and safety of remifentanil and sufentanil when used for long-term analgesiasedation
The special characteristics of intensive care patients organ insufficiencies etc regularly cause an accumulation of the analgesics sedatives and adjuvants used Clinically this complicates the calculation of weaning and extubation times often making mechanical ventilation necessary for longer periods than desired and also extending the stay of patients in the intensive care unit Reducing weaning times and the duration of intensive care treatment by optimizing analgesiasedation could furthermore lead to a reduction in typical complications such as ventilator-associated pneumonia or delirium
The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary depression and rapid onset of effect and in particular a short dura-tion of effect and absence of accumulation or development of active metabolites Remifentanil is an ultra-short acting µ-agonist which is due to its molecular structure metabolized organ-independently by unspecific blood and tissue esterases with the substance being degraded within only a few minutes and the resulting metabolites being virtually ineffective at the µ-receptor Sufentanil on the other hand is mainly metabolized by the cytochrome P-450-3A4 enzyme in the liver and small intestine
To date only one study with a small sample size is available on the comparison of the effectiveness and safety of remifentanil and sufentanil when used for long-term analgesiasedation
Detailed Description:
None
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 |
|---|---|---|---|
| EudraCT 2006-001276-20 | None | None | None |