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

Propofol Clinical Trial

— TCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800288
• Other study ID #: BenzoMAST
• Status: Completed
• Start date: March 30, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Propofol

Intervention

Drug:
• Propofol
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

Locations

Country	Name	City	State
Italy	ULSS2	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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