Unconsciousness Clinical Trial
Official title:
Performance of Two Different Ke0s in the Same Pharmacokinetic Propofol Model. Study on Loss and Recovery of Consciousness
The aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of consciousness, using Marsh's pharmacokinetic model.The hypothesis to be tested was that the Ce of propofol predicted by the slow ke0 in the loss and recovery of consciousness is similar, differently from the fast ke0.
Introduction: The ke0 can be defined as the proportional variation of the gradient of concentration between the plasma and the effect-site in relation to the unit of time. Theoretically, the higher the value of the ke0, the faster the drug enters the effect-site. Therefore, drugs with short T½ke0 have high ke0s and fast onset of action. The aim of this study was to assess the clinical performance of two different ke0s (fast and slow) in terms of propofol effect-site concentration (Ce) during the loss and recovery of consciousness, using Marsh's pharmacokinetic model. Method: Twenty healthy male adult volunteers participated in this study. Propofol was first administered to the individual volunteer using Marsh's pharmacokinetic target-controlled infusion model with ke0 of 1.21 min-1 and, on another opportunity, with the same pharmacokinetic model but ke0 of 0.26 min-1. Propofol was infused in plasma target-concentration of 3.0 µg.mL-1. Loss and recovery of consciousness was defined as response of the volunteer to verbal stimulus. The Ce was registered at the moments of loss and recovery of consciousness. Results: At loss and recovery of consciousness, propofol Ce means predicted by the fast ke0 were different (3.64 ± 0.78 and 1.47 ± 0.29 µg.mL-1, respectively, p < 0.0001), whereas with the slow ke0 the predicted Ce means were similar (2.20 ± 0.70 and 2.13 ± 0.43 µg.mL-1, respectively, p = 0.5425). Conclusion: It can be concluded that slow ke0 (0.26 min-1) incorporated into Marsh's pharmacokinetic model showed better clinical performance than fast ke0 (1.21 min-1), since the predicted effect-site concentrations of propofol at loss and recovery of consciousness were similar. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06036732 -
A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score
|
||
| Completed |
NCT03913065 -
Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest
|
||
| Completed |
NCT03290859 -
Race-Specific Propofol Titration to Effect for Procedural Sedation
|
||
| Completed |
NCT03699306 -
Comparison of Three Methods for NG Tube Placement
|
N/A | |
| Completed |
NCT02624401 -
The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)
|
Phase 4 | |
| Withdrawn |
NCT01730001 -
Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services
|
N/A | |
| Completed |
NCT05587179 -
The Impact of Different Recovery Positions on the Perfusion of the Lower Forearm and Comfort
|
N/A | |
| Completed |
NCT05496985 -
Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）
|
N/A | |
| Completed |
NCT03284307 -
UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study
|
Phase 4 |