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
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Lidocaine

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