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)
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 |
Verified date | April 2024 |
Source | University of Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Treviso Regional Hospital | Treviso | TV |
Lead Sponsor | Collaborator |
---|---|
University of Padova |
Italy,
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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