Effectiveness, safety, and pharmacokinetic and pharmacodynamic characteristics of microemulsion propofol in patients undergoing elective surgery under total intravenous anaesthesia

The aims of this study were to investigate the effectiveness, safety, pharmacokinetics, and pharmacodynamics of microemulsion propofol, Aquafol™ (Daewon Pharmaceutical Co., Ltd, Seoul, Republic of Korea). In total, 288 patients were randomized to receive 1% Aquafol™ or 1% Diprivan® (AstraZeneca, Lon...

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Bibliographic Details
Published in:British journal of anaesthesia : BJA 2010-05, Vol.104 (5), p.563-576
Main Authors: Jung, J.A., Choi, B.M., Cho, S.H., Choe, S.M., Ghim, J.L., Lee, H.M., Roh, Y.J., Noh, G.J.
Format: Article
Language:English
Subjects:
Adult
anaesthetics i.v
anaesthetics i.v., propofol
Analgesics, Opioid - administration & dosage
Anesthesia
Anesthesia, Intravenous - methods
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Anesthetics, Intravenous - adverse effects
Anesthetics, Intravenous - blood
Anesthetics, Intravenous - chemistry
Biological and medical sciences
Chemistry, Pharmaceutical
Double-Blind Method
drug
Drug Administration Schedule
Elective Surgical Procedures
Emulsions
Female
Humans
Male
Medical sciences
Middle Aged
model, pharmacodynamic
Pain - chemically induced
Pain Measurement - methods
Pain, Postoperative - prevention & control
pharmacodynamic
pharmacokinetics
pharmacokinetics, propofol
Postoperative Nausea and Vomiting - chemically induced
propofol
Propofol - adverse effects
Propofol - blood
Propofol - chemistry
safety
safety, drug
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Summary:The aims of this study were to investigate the effectiveness, safety, pharmacokinetics, and pharmacodynamics of microemulsion propofol, Aquafol™ (Daewon Pharmaceutical Co., Ltd, Seoul, Republic of Korea). In total, 288 patients were randomized to receive 1% Aquafol™ or 1% Diprivan® (AstraZeneca, London, UK) (n=144, respectively). A 30 mg test dose of propofol was administered i.v. over 2 s for assessing injection pain. Subsequently, a bolus of propofol 2 mg kg−1 (−30 mg) was administered. Anaesthesia was maintained with a variable rate infusion of propofol and a target-controlled infusion of remifentanil. Mean infusion rates of both formulations and times to loss of consciousness (LOC) and recovery of consciousness (ROC) were recorded. Adverse events and pharmacokinetic and pharmacodynamic characteristics were evaluated. Mean infusion rate of Aquafol™ was not statistically different from that of Diprivan® (median: 6.2 vs 6.3 mg kg−1 h−1). Times to LOC and ROC were slightly prolonged in Aquafol™ (median: 21 vs 18 s, 12.3 vs 10.8 min). Aquafol™ showed similar incidence of adverse events to Diprivan®. Aquafol™ (vs Diprivan®) caused more severe (median VAS: 72.0 vs 11.5 mm) and frequent (81.9 vs 29.2%) injection pain. The dose-normalized AUClast of Aquafol™ and Diprivan® was 0.71 (0.19) and 0.74 (0.20) min litre−1. The V1 of both formulations were proportional to lean body mass. Sex was a significant covariate for k12 and Ce50 of Aquafol™, and for ke0 of Diprivan®. Aquafol™ was as effective and safe as Diprivan®, but caused more severe and frequent injection pain. Aquafol™ demonstrated similar pharmacokinetics to Diprivan®.
ISSN:0007-0912
1471-6771
DOI:10.1093/bja/aeq040