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NCT06135688 Clinical Trial

Effects of Lidocaine Bolus and Infusion on Bispectral Index Values and Spectrum During Anesthesia Maintenance

Lidocaine Clinical Trial

Official title:
Effects of Lidocaine Bolus and Continuous Infusion on Bispectral Index Values and Spectrum During Maintenance of Total Intravenous Anesthesia With Target Controlled Infusion (Schnider Model)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06135688
Other study ID # LidoMAST
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 18, 2023
Est. completion date March 15, 2024

Study information
Verified date April 2024
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenance delivered with target controlled infusion (TCI) with stable Concnetration at the effector site of Propofol (CeP)

Description:

Lidocaine has been shown to increase the hypnotic effects of Propofol, however no trials shows the effects on Bispectral Index Values (BIS) and spectral analysis during total intravenous anesthesia maintenence delivered with target controlled infusion (TCI) with stable concentration at the effector site of Propofol (CeP). Aim of this study is to analyze BIS values and power spectrum before and after a lidocaine bolus (1,5 mg/kg delivered in 10 minutes) and a subsequent continuous infusion (1,5 mg/kg/min for 30 minutes) delivered at anesthetist's discretion for postoperative analgesia.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 15, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Undergo general anesthesia with Target Controlled Infusion of Propofol (Schnider model) and Remifentanil (Minto model) and Lidocaine bolus and continuous infusion for a total of 40 minutes. Exclusion Criteria: - Neurological disease - Psychiatric disease - Obesity

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Treviso Regional Hospital Treviso TV

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 BIS values and power spectrum before and after lidocaine administration Patients will receive during anesthesia maintenance a lidocaine bolus of 1,5 mg/kg delivered in 10 minutes and a lidocaine continuous infusion of 1,5 mg/kg/h for 30 minutes We collect data about propofol concentration (ng/ml)and BIS values during general anaesthesia. We will collect BIS and TCI Propofol values during all the duration of anesthesia, form the start o anesthesia until the emergence from anesthesia
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