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

NCT05800288 | Completed DMC

• 1 other identifier: BenzoMAST
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Propofol; Anesthesia Brain Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

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

EleveldTCI; Schnider TCI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Neurological disease
• Psychiatric disease
• Obesity

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

ULSS2

Treviso, Italy

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal investigator

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: March 30, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IT (1)