Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481312
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2007-05-31
Brief Title:
Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit ICU
Sponsor:
Orion Corporation Orion Pharma
Organization:
Orion Corporation Orion Pharma
Study Overview
Official Title:
A Prospective Multi-centre Randomised Double-blind Comparison of Intravenous Dexmedetomidine With Midazolam for Continuous Sedation of Ventilated Patients in Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2009-11
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:
MIDEX
Brief Summary:
Patients in ICU who need help with their breathing are put onto a machine called a ventilator and are also given a medicine called a sedative which helps them to sleep and makes them more comfortable Midazolam is a sedative that is routinely used for these purposes
For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff light sedation
Dexmedetomidine is a new sedative for use in intensive care and in this clinical study dexmedetomidine is compared to midazolam It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them It also does not appear to affect patients breathing the purpose of this study is to test whether dexmedetomidine really does have these advantages compared to midazolam
in this study we hope to show that dexmedetomidine is at least as good as midazolam in helping patients to sleep better and making them more comfortable and that they are able to co-operate better with the staff treating them and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with midazolam
For most patients the aim of sedation is to make them sleepy but still able to respond to nursing staff light sedation
Dexmedetomidine is a new sedative for use in intensive care and in this clinical study dexmedetomidine is compared to midazolam It is thought that dexmedetomidine might be slightly better at allowing patients to be sleepy but still respond to people around them It also does not appear to affect patients breathing the purpose of this study is to test whether dexmedetomidine really does have these advantages compared to midazolam
in this study we hope to show that dexmedetomidine is at least as good as midazolam in helping patients to sleep better and making them more comfortable and that they are able to co-operate better with the staff treating them and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with midazolam
Detailed Description:
This is a phase III multi-centre prospective randomised double-blind double-dummy active comparator study The study consists of three periods screening double-dummy treatment and follow-up period
All patients admitted to ICU will be pre-screened according to inclusion and exclusion criteria prior to informed consent using available clinical data
Informed consent screening and randomisation procedures should be completed within 72 hours from the time of admission to ICU and within 48 hours from starting continuous sedation Eligible study subjects requiring light to moderate sedation Richmond Agitation-Sedation Scale RASS 0 to -3 will be randomised to either continue on midazolam or switch to dexmedetomidine Patients should not have received any other continuously or regularly administered sedative agent than midazolam infusion during the last 12 hours except for opioid analgesics Study treatments will be titrated to achieve an individually targeted sedation range determined on a daily basis Rescue treatment ie propofol boli may be given if needed to achieve the target depth of sedation Continued need for sedation will be assessed at a daily sedation stop conducted at the same time each day First sedation stop may be 12-36 hours from randomisation depending on the time of day the study subject is randomised The duration of study treatment is limited to a maximum of 14 days from randomisation Following withdrawal of sedation study subjects will be monitored for 48 hours and contacted by telephone 31 and 45 days after randomisation
All patients admitted to ICU will be pre-screened according to inclusion and exclusion criteria prior to informed consent using available clinical data
Informed consent screening and randomisation procedures should be completed within 72 hours from the time of admission to ICU and within 48 hours from starting continuous sedation Eligible study subjects requiring light to moderate sedation Richmond Agitation-Sedation Scale RASS 0 to -3 will be randomised to either continue on midazolam or switch to dexmedetomidine Patients should not have received any other continuously or regularly administered sedative agent than midazolam infusion during the last 12 hours except for opioid analgesics Study treatments will be titrated to achieve an individually targeted sedation range determined on a daily basis Rescue treatment ie propofol boli may be given if needed to achieve the target depth of sedation Continued need for sedation will be assessed at a daily sedation stop conducted at the same time each day First sedation stop may be 12-36 hours from randomisation depending on the time of day the study subject is randomised The duration of study treatment is limited to a maximum of 14 days from randomisation Following withdrawal of sedation study subjects will be monitored for 48 hours and contacted by telephone 31 and 45 days after randomisation
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