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

Sponsor
University of Padova (Other)
Overall Status
Recruiting
CT.gov ID
NCT06135688
Collaborator
(none)
20
Enrollment
1
Location
3.9
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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)
    Actual Study Start Date :
    Nov 18, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 15, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between BIS values and power spectrum before and after lidocaine administration [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]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Treviso Regional Hospital Treviso TV Italy 31100

    Sponsors and Collaborators

    • University of Padova

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Federico Linassi, MD, principal investigator, University of Padova
    ClinicalTrials.gov Identifier:
    NCT06135688
    Other Study ID Numbers:
    • LidoMAST
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 21, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 21, 2023