NCT02067936

Walking the Isobole of Drug Interaction

Walking the Isobole of Drug Interaction: Comparison of Hemodynamic Effects, Cerebral and Tissue Oxygenation for 4 Equipotent Combinations of Propofol and Remifentanil

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Hemodynamic Instability
• Disorder of Oxygen Transport
• Interaction
• Anesthesia

Interventions

Type	Name	Description
DRUG	Group A propofol + remifentanil	Predicted TOL90% according to Bouillon model
DRUG	Group B propofol + remifentanil	TOL 90% according to the Bouillon interaction model
DRUG	Group C propofol + remifentanil	TOL 90% according to the Bouillon interaction model
DRUG	group D propofol + remifentanil	TOL 90% according to the Bouillon interaction model

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-02-20
• Last updated: 2015-12-04

Locations

1 site across 1 country: Netherlands