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

NCT ID: NCT05800288

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2023-09-30

Brief 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.

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.

Conditions

Propofol; Anesthesia Brain Monitoring

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Propofol

Intervention Type: 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

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)

Propofol

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Federico Linassi

MD, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ULSS2

Treviso, , Italy

Countries

Italy

Other Identifiers

BenzoMAST

Identifier Type: -

Identifier Source: org_study_id