Continuous Sedation in Initially Sedated Adults in ICU Clinical Trial
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
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 patient's 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.
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 (i.e. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00479661 -
Dexmedetomidine Versus Propofol for Continuous Sedation in the Intensive Care Unit (ICU)
|
Phase 3 |