Safety and efficacy of analgesia-based sedation using remifentanil versus standard hypnotic-based regimens in intensive care unit (ICU) patients with brain injuries: a randomised, controlled trial

Completed

• Conditions: eurotrauma; Injury, Occupational Diseases, Poisoning; Intracranial injury

• Registration Number: ISRCTN50308308
• Lead Sponsor: GlaxoSmithKline (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

1. Acute, severe neurological insult/injury
2. Elective or emergency neurosurgery
3. Aged 18 - 80 years
4. Weighed less than or equal to 120 kg
5. Admitted into the ICU within the past 24 hours, were intubated and were expected to require mechanical ventilation for 1 - 5 days

Exclusion Criteria

1. Had or were likely to require:
1.1. Long-acting (or continuous administration of) neuromuscular blocking drugs to facilitate mechanical ventilation during the study period
1.2. Barbiturate administration prior to or during the study period
1.3. Epidural block during the maintenance or extubation phases of the study
2. Failed to demonstrate signs of recovery/responsiveness within 6 hours of stopping any analgesia/sedation regimen in use at the time of screening for study entry
3. Likely to require a tracheostomy with spontaneous ventilation within five days of starting study drug treatment
4. Suffered severe, associated traumatic injury, had a neurological condition that might affect the ability to assess their Sedation-Agitation Scale (SAS) score, were admitted for status epilepticus, had moderate or severe renal impairment (predicted creatinine clearance of less than 50 ml/min)
5. History of allergy to opioids, benzodiazepines, propofol or of alcohol/drug abuse
6. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified