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Open Access

The safety of remifentanil administered for up to 5 days in ICU patients with neurotrauma

  • S Stergiopoulos1,
  • A Karabinis2,
  • K Mandragos3,
  • A Komnos4,
  • J Soukup5,
  • B Speelberg6 and
  • A Kirkham7
Critical Care20048(Suppl 1):P235

https://doi.org/10.1186/cc2702

Published: 15 March 2004

Keywords

MorphineFentanylMidazolamMean Arterial PressureRemifentanil

Introduction

Remifentanil hydrochloride (Remi) is being increasingly used in the critically ill. Remi-based analgesia and sedation supplemented with propofol (P) or midazolam (Mid) was compared with a hypnotic-based technique using fentanyl (Fent) or morphine (Morph) in combination with P or Mid for up to 5 days in 161 mechanically ventilated neurotrauma patients.

Methods

Open-label treatment with Remi, Fent or Morph was randomised 2:1:1. Remi infusion was started at 9 μg/kg/hour and titrated to effect. Supplemental P (days 1–3) or Mid (days 4–5) was introduced at an infusion rate of 18 μg/kg/hour to provide optimal sedation (SAS 1–3) and analgesia (none/mild pain). Fent or Morph were administered with P or Mid according to routine practice. The mean arterial pressure (MAP), heart rate (HR), intracranial pressure (ICP) and cerebral perfusion pressure (CPP) were measured at the time of and 10 min following dose titrations and at 1–4 hour intervals. Adverse events were recorded during the treatment and post-treatment period.

Results

The median (range) duration of administration of Remi, Fent and Morph were 47.3 (3.8–120.0), 35.2 (0.2–120.0) and 40.9 (4.5–120.0) hours, respectively. Twenty-three patients received Remi for 5 days. Comparing Remi with Fent and Morph, no statistically significant differences were observed in the incidence of adverse events or haemodynamic measures. Table 1 presents the most common adverse events (≥5%) number of patients (%), and haemodynamics.

Table 1

 

Remi (n = 84)

Fent (n = 37)

Morph (n = 40)

Bradycardiaa

5 (6%)

2 (5%)

2 (5%)

Hypotensiona

12 (14%)

4 (11%)

2 (5%)

Polyuriaa

3 (4%)

2 (5%)

0

MAP (mmHg)b

73 (18.4)

71 (20.6)

74 (19.0)

HR (bpm)b

64 (18.1)

66 (22.1)

67 (19.9)

ICP (mmHg)b*

10.8 (4.2),

12.3 (7.7),

11.2 (6.4),

 

n = 20

n = 10

n = 12

CPP (mmHg)b*

62.8 (18.1),

70.6 (12.5),

69.3 (14.0),

 

n = 16

n = 7

n = 10

aFisher's exact test. bWeighted mean (SD). *Analysis of covariance adjusting for baseline.

Conclusion

Remifentanil was well tolerated and provided acceptable haemodynamic stability in intensive care patients with neurotrauma when administered for up to 5 days.

Authors’ Affiliations

(1)
General Hospital of Nikaia, Piraeus, Greece
(2)
Genimatas General Hospital, Greece
(3)
Red Cross Hospital of Athens, Greece
(4)
Koutlibanio General Hospital of Larisa, Greece
(5)
Martin-Luther-Universitat, Halle, Germany
(6)
St Elizabeth Ziekenhuis, Tilburg, The Netherlands
(7)
GlaxoSmithKline, UK

Copyright

© BioMed Central Ltd. 2004

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