Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2025-12-17 @ 2:06 AM
Study NCT ID:
NCT05800288
Status:
None
Last Update Posted:
2023-10-19 00:00:00
First Post:
2023-03-23 00:00:00
Brief Title:
Effect of Midazolam Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Models
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Clinical Comparison Between Two Propofol TCI Models(Eleveld and Schnider) for General Anaesthesia After Premedication With Midazolam
Status:
None
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCI
Brief Summary:
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.
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.
Detailed Description:
During recent years Eleveld and colleagues ideated a new propofol pharmacokineticpharmacodynamic PKPD 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 003 mgkg 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
However no trials have compared the Eleveld to the Schnidermodel after a premedication with Midazolam bolus 003 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None