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

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

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.

Study Overview

• Status: Completed
• Conditions: Propofol; Anesthesia Brain Monitoring
• Intervention / Treatment: Drug: Propofol

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Treviso, Italy
    • ULSS2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, and Midazolam premedication will be recruited

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	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
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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: BenzoMAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No