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No trials have evaluated the effect of a Midazolam bolus (routinely used for premedication before general anesthesia) on the Concnetration at the effector site of Propofol (CeP) of Eleveld and Schnider TCI models, routinely used for general anesthesia delivery.
During recent years Eleveld and colleagues ideated a new propofol pharmacokinetic/pharmacodynamic (PK/PD) model for total intravenous anaesthesia with target controlled infusion (TIVA-TCI) pumps that has been proposed to have slightly better predictive performance for measured propofol plasma concentrations compared with those of the Marsh and Schnider models, and suitable for children, adults, older subjects, and obese adults, being considered as a "General purpose" model.
However, no trials have compared the Eleveld to the Schnidermodel after a premedication with Midazolam bolus (0.03 mg/kg) from a clinical point of view; so, this study aimed toevaluate midazolam effect on the estimated effector site concentration of the two models (CePE and CePS, respectively) at loss of responsiveness (LoR), during anaesthesia maintenance (Bispectral Index [BIS] 40-60) and return of responsiveness (RoR). The study also compared the incidence of deepening or superficializing anaesthesia (defined respectively as lowering or increasing in out-of-target BIS after initial CeP detection), as well as unwanted anaesthesia events: burst suppression (BSupp, identified as a burst suppression ratio [BSR] >0) and unwanted spontaneous responsiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EleveldTCI | Patients who received Midazolam premedication bolus (0.03 mg/kg) before general anesthesia conducted with Eleveld TCI model (this model was choosen at anesthesiologist's discreption) |
| |
| Schnider TCI | Patients who received Midazolam premedication bolus (0.03 mg/kg) before general anesthesia conducted with SchniderTCI model (this model was choosen at anesthesiologist's discreption) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Patients will be observationally included in the Elveld TCI or Schnider TCI group. The TCI model is choosen at anesthesiologist's discreption, as suggested in literature |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between Concentration at the effector site of Propofol after Midazolam | Discover if, after astandard premedication with midazolam bolus, there are differences between Concentrations at the effector site of Propofol using the Eleveld TCI model versus Schnider TCI model, during standard general anaesthesia conducted with Propofol and remifenatnil delivered with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia | We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start of midazolam bolus until the emergence from anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, and Midazolam premedication will be recruited
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULSS2 | Treviso | Italy |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |