Anesthesia Clinical Trial
Official title:
Walking the Isobole of Drug Interaction: Comparison of Hemodynamic Effects, Cerebral and Tissue Oxygenation for 4 Equipotent Combinations of Propofol and Remifentanil
The investigators study whether four equipotent combinations of propofol and remifentanil (as predicted by interaction models for "tolerance of laryngoscopy") result in identical haemodynamic conditions, independent of their relative different balance between the concentration of propofol and remifentanil.
In anesthesia, the synergistic interaction between hypnotics and opioids is applied daily to
give adequate anesthesia and analgesia at significantly lower doses compared with the ones
needed if only one drug was given to reach the same effect. A lot of research has been done
to quantify these interactions with a focus on the desired effects (Tolerance of
laryngoscopy, tolerance of shake and shout etc...), but the simultaneous interaction on the
unwanted side effects is less well described. The response surface model of Bouillon et al.
and other models predict combinations of propofol and remifentanil effect-site
concentrations that lead to an equipotent desired effect. Due to the availability of the
models, the anesthesiologists now could use the knowledge on interactions to target specific
effects more accurately, using predefined equipotent combinations of drugs: for instance, a
desirable 90% probability of tolerance of laryngoscopy (TOL90) in the population can be
reached through either a high propofol/low remifentanil combination, but equally well
through a low propofol-high remifentanil combination.
However, at this time it is not known whether some of the combinations of propofol and
remifentanil have a favorable hemodynamic stability compared to other equipotent
combinations. The researcher in this study want to determine whether equipotent combinations
of remifentanil and propofol (all deliberately selected to evoke 90% probability of
"tolerance to laryngoscopy"), result in different effects on the undesired side effects of
anesthetics, such as hemodynamic instability (hypotension, changes in heart rate or cardiac
output), decreases in cerebral or tissue oxygenation (both measured with near infrared
spectroscopy).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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