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

British Journal of Anaesthesia

Volumn 104, Issue 5, 2010, Pages 563-576

  Jung, J A ^a   Choi, B M ^b   Cho, S H ^a   Choe, S M ^c   Ghim, J L ^d   Lee, H M ^a   Roh, Y J ^e   Noh, G J ^a  

^a University of Ulsan College of Medicine   (South Korea)

^b National Medical Center   (South Korea)

^c Yangsan Hospital   (South Korea)

^d Yeungnam University Hospital   (South Korea)

^e Seoul National University   (South Korea)

Author keywords

Anaesthetics i.v., propofol; Model, pharmacodynamic; Pharmacokinetics, propofol; Safety, Drug

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; AQUAFOL; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; BILIRUBIN GLUCURONIDE; CHOLESTEROL; CREATININE; ESMOLOL; FENTANYL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; KETOROLAC; LABETALOL; LOW DENSITY LIPOPROTEIN CHOLESTEROL; MIDAZOLAM; NICARDIPINE; NITROGEN; ONDANSETRON; PHENYLEPHRINE; PROPOFOL; REMIFENTANIL; ROCURONIUM; TRIACYLGLYCEROL; UNCLASSIFIED DRUG; UREA;

ADULT; ANESTHESIA; ANESTHESIA INDUCTION; ARTICLE; BRADYCARDIA; BREAST SURGERY; CLINICAL TRIAL; COLORECTAL SURGERY; CONSCIOUSNESS LEVEL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; ELECTIVE SURGERY; FEMALE; GLUCOSURIA; HUMAN; HYPERTENSION; HYPOTENSION; INFUSION RATE; INJECTION PAIN; INTERNATIONAL NORMALIZED RATIO; LEAN BODY WEIGHT; MAJOR CLINICAL STUDY; MALE; MICROEMULSION; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PANCREATITIS; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; POSTOPERATIVE COMPLICATION; POSTOPERATIVE HEMORRHAGE; POSTOPERATIVE NAUSEA AND VOMITING; POSTOPERATIVE PAIN; PRIORITY JOURNAL; PROTEINURIA; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; SEX DIFFERENCE; SIDE EFFECT; STOMACH SURGERY; TACHYCARDIA; THROMBOCYTOPENIA; TRIACYLGLYCEROL BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL;

EID: 77951287918     PISSN: 00070912     EISSN: 14716771     Source Type: Journal    
DOI: 10.1093/bja/aeq040     Document Type: Article

References (29)

1. Baker MT, Naguib M. Propofol: the challenges of formulation. Anesthesiology 2005; 103: 860-876
2. Kim KM, Choi BM, Park SW, et al. Pharmacokinetics and pharmacodynamics of propofol microemulsion and lipid emulsion after an intravenous bolus and variable rate infusion. Anesthesiology 2007; 106: 924-934
3. Lee EH, Lee SH, Park DY, et al. Physicochemical properties, pharmacokinetics, and pharmacodynamics of a reformulated microemulsion propofol in rats. Anesthesiology 2008; 109: 436-447
4. CTEP. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Betheda Division of Cancer Treatment and Diagnosis (DCPT). National Cancer Institute (NCI), U.S. National Institutes of Health (NIH), 2006
5. Orringer EP, Casella JF, Ataga KI, et al. Purified poloxamer 188 for treatment of acute vaso-occlusive crisis of sickle cell disease: a randomized controlled trial. J Am Med Assoc 2001; 286: 2099-2106
6. Jewell RC, Khor SP, Kisor DF, LaCroix KA, Wargin WA. Pharmacokinetics of RheothRx injection in healthy male volunteers. J Pharm Sci 1997; 86: 808-812
7. Schaer GL, Spaccavento LJ, Browne KF, et al. Beneficial effects of RheothRx injection in patients receiving thrombolytic therapy for acute myocardial infarction. Results of a randomized, doubleblind, placebo-controlled trial. Circulation 1996; 94: 298-307
8. Ballas SK, Files B, Luchtman-Jones L, et al. Safety of purified poloxamer 188 in sickle cell disease: phase I study of a non-ionic surfactant in the management of acute chest syndrome. Hemoglobin 2004; 28: 85-102
9. Dutta S, Ebling WF. Emulsion formulation reduces propofol's dose requirements and enhances safety. Anesthesiology 1997; 87: 1394-1405
10. Olufolabi AJ, Gan TJ, Lacassie HJ, White WD, Habib AS. A randomized, prospective double-blind comparison of the efficacy of generic propofol (sulphite additive) with diprivan. Eur J Anaesthesiol 2006; 23: 341-345
11. Collins SL, Moore RA, McQuay HJ. The visual analogue pain intensity scale: what is moderate pain in millimetres? Pain 1997; 72: 95-97
12. Minto CF, Schnider TW, Egan TD, et al. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology 1997; 86: 10-23
13. Ausems ME, Vuyk J, Hug CC Jr, Stanski DR. Comparison of a computer-assisted infusion versus intermittent bolus administration of alfentanil as a supplement to nitrous oxide for lower abdominal surgery. Anesthesiology 1988; 68: 851-861
14. White LA, Vanarase M, Brockbank K, Barrett RF. Patient-controlled analgesia and postoperative nausea and vomiting: efficacy of a continuous infusion of ondansetron. Anaesthesia 2001; 56: 365-369
15. Kang SH, Poynton MR, Kim KM, et al. Population pharmacokinetic and pharmacodynamic models of remifentanil in healthy volunteers using artificial neural network analysis. Br J Clin Pharmacol 2007; 64: 3-13
16. Green B, Duffull SB. What is the best size descriptor to use for pharmacokinetic studies in the obese? Br J Clin Pharmacol 2004; 58: 119-133
17. Bouillon T, Shafer SL. Does size matter? Anesthesiology 1998; 89: 557-560
18. Beal S, Sheiner L. NONMEM User's Guides Part V Introductory Guide. San Francisco: NONMEM Project Group, University of California, 1992
19. Hooker AC, Staatz CE, Karlsson MO. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res 2007; 24: 2187-2197
20. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther 2007; 82: 17-20
21. Parke J, Holford NH, Charles BG. A procedure for generating bootstrap samples for the validation of nonlinear mixed-effects population models. Comput Methods Programs Biomed 1999; 59: 19-29
22. el-Ebiary M, Torres A, Ramirez J, Xaubet A, Rodriguez-Roisin R. Lipid deposition during the long-term infusion of propofol. Crit Care Med 1995; 23: 1928-1930
23. Kee S, Yu W. Implication of the accessory left hepatic artery in curative surgery for gastric cancer. J Korean Surg Soc 1998; 54: 688-694
24. Okano S, Sawai K, Taniguchi H, Takahashi T. Aberrant left hepatic artery arising from the left gastric artery and liver function after radical gastrectomy for gastric cancer. World J Surg 1993; 17: 70-74
25. Szebeni J. Complement activation-related pseudoallergy caused by amphiphilic drug carriers: the role of lipoproteins. Curr Drug Deliv 2005; 2: 443-449
26. McNeill O, Kerridge RK, Boyle MJ. Review of procedures for investigation of anaesthesia-associated anaphylaxis in Newcastle, Australia. Anaesth Intensive Care 2008; 36: 201-207
27. Grindel JM, Jaworski T, Piraner O, Emanuele RM, Balasubramanian M. Distribution, metabolism, and excretion of a novel surface-active agent, purified poloxamer 188, in rats, dogs, and humans. J Pharm Sci 2002; 91: 1936-1947
28. Schnider TW, Minto CF, Gambus PL, et al. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology 1998; 88: 1170-1182
29. Lysakowski C, Dumont L, Pellegrini M, Clergue F, Tassonyi E. Effects of fentanyl, alfentanil, remifentanil and sufentanil on loss of consciousness and bispectral index during propofol induction of anaesthesia. Br J Anaesth 2001; 86: 523-527