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NCT Number: NCT06135688

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

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)

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Key information

Conditions

Anesthesia Brain Monitoring Lidocaine

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Treviso Regional Hospital

Treviso, TV, 31100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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