Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308]

This randomised, open-label, observational, multicentre, parallel group study assessed the safety and efficacy of analgesia-based sedation using remifentanil in the neuro-intensive care unit. Patients aged 18-80 years admitted to the intensive care unit within the previous 24 hours, with acute brain...

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Bibliographic Details
Published in:Critical care (London, England) England), 2004-08, Vol.8 (4), p.R268-R280
Main Authors: Karabinis, Andreas, Mandragos, Kostas, Stergiopoulos, Spiros, Komnos, Apostolos, Soukup, Jens, Speelberg, Ben, Kirkham, Andrew J T
Format: Article
Language:English
Subjects:
Adjuvants, Anesthesia - adverse effects
Adjuvants, Anesthesia - pharmacology
Adjuvants, Anesthesia - therapeutic use
Adolescent
Adult
Aged
Analgesics, Opioid - pharmacology
Analgesics, Opioid - therapeutic use
Brain Injuries - physiopathology
Brain Injuries - therapy
Drug Monitoring
Female
Fentanyl - adverse effects
Fentanyl - pharmacology
Fentanyl - therapeutic use
Humans
Hypnotics and Sedatives - adverse effects
Hypnotics and Sedatives - pharmacology
Hypnotics and Sedatives - therapeutic use
Intensive Care Units
Male
Midazolam - adverse effects
Midazolam - pharmacology
Midazolam - therapeutic use
Middle Aged
Neurosurgical Procedures
Piperidines - pharmacology
Piperidines - therapeutic use
Postoperative Care
Propofol - adverse effects
Propofol - pharmacology
Propofol - therapeutic use
Respiration, Artificial
Time Factors
Treatment Outcome
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Summary:This randomised, open-label, observational, multicentre, parallel group study assessed the safety and efficacy of analgesia-based sedation using remifentanil in the neuro-intensive care unit. Patients aged 18-80 years admitted to the intensive care unit within the previous 24 hours, with acute brain injury or after neurosurgery, intubated, expected to require mechanical ventilation for 1-5 days and requiring daily downward titration of sedation for assessment of neurological function were studied. Patients received one of two treatment regimens. Regimen one consisted of analgesia-based sedation, in which remifentanil (initial rate 9 microg kg(-1) h(-1)) was titrated before the addition of a hypnotic agent (propofol [0.5 mg kg(-1) h(-1)] during days 1-3, midazolam [0.03 mg kg(-1) h(-1)] during days 4 and 5) (n = 84). Regimen two consisted of hypnotic-based sedation: hypnotic agent (propofol days 1-3; midazolam days 4 and 5) and fentanyl (n = 37) or morphine (n = 40) according to routine clinical practice. For each regimen, agents were titrated to achieve optimal sedation (Sedation-Agitation Scale score 1-3) and analgesia (Pain Intensity score 1-2). Overall, between-patient variability around the time of neurological assessment was statistically significantly smaller when using remifentanil (remifentanil 0.44 versus fentanyl 0.86 [P = 0.024] versus morphine 0.98 [P = 0.006]. Overall, mean neurological assessment times were significantly shorter when using remifentanil (remifentanil 0.41 hour versus fentanyl 0.71 hour [P = 0.001] versus morphine 0.82 hour [P < 0.001]). Patients receiving the remifentanil-based regimen were extubated significantly faster than those treated with morphine (1.0 hour versus 1.93 hour, P = 0.001) but there was no difference between remifentanil and fentanyl. Remifentanil was effective, well tolerated and provided comparable haemodynamic stability to that of the hypnotic-based regimen. Over three times as many users rated analgesia-based sedation with remifentanil as very good or excellent in facilitating assessment of neurological function compared with the hypnotic-based regimen. Analgesia-based sedation with remifentanil permitted significantly faster and more predictable awakening for neurological assessment. Analgesia-based sedation with remifentanil was very effective, well tolerated and had a similar adverse event and haemodynamic profile to those of hypnotic-based regimens when used in critically ill neuro-intensive care uni
ISSN:1364-8535
1466-609X
DOI:10.1186/cc2896