Hostname: page-component-cd9895bd7-jn8rn Total loading time: 0 Render date: 2024-12-19T12:31:51.593Z Has data issue: false hasContentIssue false
  • English
  • Français

A randomized, prospective double-blind comparison of the efficacy of generic propofol (sulphite additive) with Diprivan®

Published online by Cambridge University Press:  27 January 2006

A. J. Olufolabi ,
T. J. Gan ,
H. J. Lacassie ,
W. D. White  and
A. S. Habib
A. J. Olufolabi
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
T. J. Gan
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
H. J. Lacassie
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
W. D. White
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
A. S. Habib
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
Get access

Extract

Summary

Background and objective: We compared the dose requirement and side effect profile of total intravenous anaesthesia using Diprivan® to generic propofol at a specific anaesthetic target level utilizing the bispectral index monitor to determine efficacy differences between the two products. Methods: Sixty women undergoing abdominal hysterectomy were induced with propofol 2 mg kg−1 and maintained with infusion (20–200 μg kg−1 min−1) adjusted to maintain a bispectral index of 50–65. Plasma propofol concentration was measured at 1 and 2 h post induction in 25 patients. Results: Mean (SD) drug doses adjusted for weight and time were similar in the Diprivan® and generic propofol groups: 90 (30) μg kg−1 min−1 vs. 90 (20) μg kg−1 min−1 respectively. Mean (SD) plasma propofol levels at 1 and 2 h were also similar (3.0 (1.0) μg mL−1 vs. 3.6 (1.4) μg mL−1, P = 0.2 and 3.0 (1.9) μg mL−1 vs. 3.4 (1.6) μg mL−1, P = 0.58). Conclusions: Diprivan® and generic propofol have similar efficacy at a specified, bispectral index-defined, depth of anaesthesia.

Keywords

ANAESTHETICS INTRAVENOUS, propofolDRUGS GENERICTHERAPEUTIC EQUIVALENCYANESTHESIA, GENERAL, bispectral index
Type
Original Article
Information
European Journal of Anaesthesiology , Volume 23 , Issue 4 , April 2006 , pp. 341 - 345
Copyright
© 2006 European Society of Anaesthesiology

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

DIPRIVAN® (PROPOFOL). Injectable Emulsion Professional Information Brochure, AstraZeneca Pharmaceuticals LP, Wilmington, DE.
Patnaik RN, Lesko LJ, Chen ML, Williams RL, and the FDA Individual Bioequivalence Working Group. Individual bioequivalence: new concepts in the statistical assessment of bioequivalence metrics. Clin Pharmacokinet 1997; 33: 1–6.Google Scholar
Banahan BF, Kolassa EM. A physician survey on generic drugs and substitution of critical dose medications. Arch Int Med 1997; 157: 2080–2088.Google Scholar
Fassoulaki A, Paraskeva A, Papilas K, Patris K. Hypnotic and cardiovascular effects of proprietary and generic propofol formulations do not differ. Can J Anaesth 2001; 48: 459–461.Google Scholar
Kayali A, Tuglular I, Ertas M. Pharmacokinetics of carbamazepine. Part I: A new bioequivalency parameter based on a relative bioavailability trial. Eur J Drug Metab Pharmacokinet 1994; 19: 319–325.Google Scholar
Shao X, Li H, White PF, Klein KW, Kulstad C, Owens A. Bisulfite-containing propofol: is it a cost-effective alternative to Diprivan for induction of anesthesia? Anesth Analg 2000; 91: 871–875.Google Scholar
Ohana E, Sheiner E, Gurman GM. Accidental intra-arterial injection of propofol. Eur J Anaesthesiol 1999; 16: 569–570.Google Scholar
Brimacombe J, Gandini D, Bashford L. Transient decrease in arm blood flow following accidental intraarterial injection of propofol into left brachial artery. Anaesth Intens Care 1994; 22: 291–292.Google Scholar
Steele H, Cuthrell L. Intra arterial injection of propofol. Anesthesiology 1990; 73: 184–186.Google Scholar
Gold WM. Cholinergic pharmacology in asthma. In: Austen KF, Lichtenstein LM, eds. Asthma: Physiology, Immunopharmacology and Treatment. New York, USA: Academic Press, Inc., 1973, 123–162.
Maria Y, Vaillant P, Delorme N, Moneret-Vautrin DA. Severe complications related to metabisulfites. Rev Med Interne 1989; 10: 36–40.Google Scholar
Quedraogo N, Roux E, Forestier F, Rossetti M, Savineau JP, Marthan R. Effects of intravenous anesthetics on normal and passively sensitized human isolated airway smooth muscle. Anesthesiology 1998; 88: 317–326.Google Scholar
Pizov R, Brown RH, Weiss YS et al. Wheezing during induction of general anesthesia with and without asthma: a randomized blinded trial. Anesthesiology 1995; 82: 111–116.Google Scholar
Rieschke P, LaFleur BJ, Janicki PK. Effects of EDTA- and sulfite-containing formulations of propofol on respiratory system resistance after tracheal intubation in smokers. Anesthesiology 2003; 98: 323–328.Google Scholar
Arain SR, Navani A, Ebert TJ. The effects of thiopental and generic and nongeneric propofol on respiratory resistance during anesthetic induction in patients with reactive airways. J Clin Anesth 2002; 14: 257–261.Google Scholar
Mi WD, Sakai T, Singh H, Kudo T, Kudo M, Matsuki A. Hypnotic endpoints vs. the bispectral index, 95% spectral edge frequency and median frequency during propofol infusion with or without fentanyl. Eur J Anaesthesiol 1999; 16: 47–52.Google Scholar
Singh H. Bispectral index (BIS) monitoring during propofol-induced sedation and anaesthesia. Eur J Anaesthesiol 1999; 16: 31–36.Google Scholar
Leslie K, Sessler DI, Schroeder M, Walters K. Propofol blood concentration and the Bispectral Index predict suppression of learning during propofol/epidural anesthesia in volunteers. Anesth Analg 1995; 81: 1269–1274.Google Scholar
Doi M, Gajraj RJ, Mantzaridis H, Kenny GN. Relationship between calculated blood concentration of propofol and electrophysiological variables during emergence from anaesthesia: comparison of bispectral index, spectral edge frequency, median frequency and auditory evoked potential index. Br J Anaesth 1997; 78: 180–184.Google Scholar
Ropcke H, Konen-Bergmann M, Cuhls M, Bouillon T, Hoeft A. Propofol and remifentanil pharmacodynamic interaction during orthopedic surgical procedures as measured by effects on bispectral index. J Clin Anesth 2001; 13: 198–207.Google Scholar
Pavlin DJ, Coda B, Shen DD et al. Effects of combining propofol and alfentanil on ventilation, analgesia, sedation, and emesis in human volunteers. Anesthesiology 1996; 84: 23–37.Google Scholar
Cockshott ID, Briggs LP, Douglas EJ, White M. Pharmacokinetics of propofol in female patients. Br J Anaesth 1987; 59: 1103–1110.Google Scholar
Milne SE, Kenny GN, Schraag S. Propofol sparing effect of remifentanil using closed-loop anaesthesia. Br J Anaesth 2003; 90: 623–629.Google Scholar
Matot I, Neely CF, Katz RY, Neufeld GR. Pulmonary uptake of propofol in cats. Anesthesiology 1993; 78: 1157–1165.Google Scholar