A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT
Phase 3
Completed
- Conditions
- sedatie en beademingsedation and ventilation
- Registration Number
- NL-OMON33849
- Lead Sponsor
- PRA International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 175
Inclusion Criteria
Patients >=18 years, Clinical need for sedation or intubated, RASS = 0 to -3 (light to moderate sedation), patient should have an expected requirement for sedation >= 24 hours, Written informed consent
protocol p. 23-24
Exclusion Criteria
Acute severe intracranial or spinal neurological disorder, Uncompensated acute circulatory failure, Severe bradycardia, AV-conduction block II-III, Severe hepatic impairment, Need for muscle relaxation, Loss of hearing or vision, Burn injuries and other injuries requiring regular anaesthesia or surgery, Use of centrally acting a2-agonists or antagonists within 24 hours prior to randomisation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy variables:<br /><br>• Depth of sedation using the RASS. The target RASS range (target depth of<br /><br>sedation) should be 0 to -3 for a patient to be included in the study. The<br /><br>target may be amended during the study treatment, if clinically required. RASS<br /><br>score will be assessed approximately 2 hourly during the treatment period and<br /><br>during the 48-hour follow-up period. In addition, RASS score should be assessed<br /><br>each time rescue treatment is given to maintain the target sedation level.<br /><br>• Duration of mechanical ventilation<br /><br><br /><br>The genetic markers that will be studied in the substudy are those that relate<br /><br>to the efficacy and safety or the absorption, distribution, metabolism and<br /><br>elimination of dexmedetomidine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy variables:<br /><br>• Nurse*s assessment of subject communication with visual analogue scales (VAS)<br /><br>• Length of ICU stay</p><br>