Effect of Midazolam Bolus on Eleveld and Schnider TCI (Target Controlled Infusion) Models

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.

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Key information

Conditions

Propofol Anesthesia Brain Monitoring

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

ULSS2

Treviso, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Undergo general anaesthsia with Targted Controlld Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)after midazolam premedication

Exclusion criteria

Neurological disease
Psychiatric disease
Obesity

Treatment and study plan

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

Primary outcomes

Correlation between Concentration at the effector site of Propofol after Midazolam

Time frame: 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

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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Clinical Comparison Between Two Propofol TCI Models(Eleveld and Schnider) for General Anaesthesia After Premedication With Midazolam

Acronym: TCI

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Apr 5, 2023
Registry last updated: Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed