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Sponsored by: |
Orion Corporation, Orion Pharma |
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Information provided by: | Orion Corporation, Orion Pharma |
ClinicalTrials.gov Identifier: | NCT00479661 |
Patients in the 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. Propofol 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 propofol. 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 propofol.
In this study, we hope to show that: dexmedetomidine is at least as good as propofol in helping patients to sleep better and making them more comfortable, and that they are able to communicate and cooperate better with the staff treating them, and that patients treated with dexmedetomidine require a shorter time on the ventilator than those treated with propofol.
Condition | Intervention | Phase |
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Continuous Sedation in Initially Sedated Adults in ICU |
Drug: Dexmedetomidine Drug: Propofol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of Intravenous Dexmedetomidine With Propofol for Continuous Sedation of Ventilated Patients in Intensive Care Unit |
Estimated Enrollment: | 500 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Dexmedetomidine
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Drug: Dexmedetomidine
Continuous infusion
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2: Active Comparator
Propofol
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Drug: Propofol
Continuous infusion
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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 propofol or switch to dexmedetomidine. Patients should not have received any other continuously or regularly administered sedative agent than propofol 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. midazolam 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Esko Ruokonen, MD | +358 17 173424 | esko.ruokonen@kuh.fi |
Principal Investigator: | Esko Ruokonen, MD | Kuopio University Hospital |
Study Director: | Kati Kaijasilta, MSc (Pharm) | Orion Corporation, Orion Pharma |
Responsible Party: | Orion corporation, Orion Pharma, Clinical R&D ( Kati Kaijasilta ) |
Study ID Numbers: | 3005012, EudraCT 2006-006030-17 |
Study First Received: | May 25, 2007 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00479661 History of Changes |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency; Switzerland: Swissmedic |
initial sedation mechanical ventilation |
Anesthetics, Intravenous Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Anesthetics Central Nervous System Depressants Adrenergic Agonists |
Anesthetics, General Analgesics, Non-Narcotic Hypnotics and Sedatives Dexmedetomidine Analgesics Peripheral Nervous System Agents Propofol |
Anesthetics, Intravenous Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Adrenergic Agonists Pharmacologic Actions |
Sensory System Agents Anesthetics, General Analgesics, Non-Narcotic Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Dexmedetomidine Analgesics Propofol Central Nervous System Agents |