A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH PROPOFOL FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT
Phase 3
Completed
- Conditions
- zenuwstelsel en ademhalingsstelseldifferent indications: respiratory insufficiencypost-surgery
- Registration Number
- NL-OMON31109
- Lead Sponsor
- PRA International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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, Use of centrally acting a2-agonists or antagonists
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<br /><br>a patient to be included in the study. The target may be amended during the<br /><br>study treatment, if clinically<br /><br>required. RASS score will be assessed approximately 2 hourly during the<br /><br>treatment period and during the<br /><br>48-hour follow-up period. In addition, RASS score should be assessed each time<br /><br>rescue treatment is given<br /><br>to maintain the target sedation level.<br /><br>• Duration of mechanical ventilation</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>