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Related Experiment Videos

How do anesthesiologists select patients when introducing a new drug into practice?

M F Roizen1, T H Stanley, R A Thisted

  • 1Department of Anesthesia and Critical Care, University of Chicago, Illinois 60637.

Anesthesia and Analgesia
|October 1, 1993
PubMed
Summary

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Anesthesiologists initially used propofol for healthier patients, gradually expanding its use to sicker individuals as experience grew. This postmarketing study tracked propofol adoption patterns in anesthesia.

Area of Science:

  • Anesthesiology
  • Pharmacology
  • Clinical Research

Background:

  • Propofol (Diprivan) received FDA approval in 1989.
  • A Phase IV postmarketing study was initiated to evaluate its adoption.
  • Stuart Pharmaceuticals sponsored this study as part of its marketing strategy.

Purpose of the Study:

  • To test the hypothesis that anesthesiologists' use of propofol evolves over time.
  • To determine if initial propofol use was limited to younger, healthier patients.
  • To assess if experienced anesthesiologists later used propofol for older, sicker patients.

Main Methods:

  • A large-scale, multicenter Phase IV study involving 1722 institutions and 1819 anesthesiologists.
  • Data collected voluntarily from 25,981 patients using standardized forms.

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  • Analysis by an independent team of anesthesiologists and epidemiologists to compare early vs. later patient cohorts within sequential study steps.

    • Main Results:

    • Physicians initially administered propofol to patients with fewer comorbidities than the general population.
    • Early propofol recipients had lower rates of hypertension (10% vs. 16%) and diabetes (3% vs. 10%) compared to general population averages.
    • The study design involved three sequential steps of increasing propofol utilization for anesthesia induction and maintenance.

    Conclusions:

    • The study supports the hypothesis that propofol adoption by anesthesiologists follows an experience-based progression.
    • Initial use was concentrated in lower-risk patient groups.
    • Further analysis would be needed to confirm the shift to higher-risk patients over time.