Anesthesia Brain MonitoringNCT06135688
Effects of Lidocaine Bolus and Infusion on Bispectral Index Values and Spectrum During Anesthesia Maintenance
An observational study of Anesthesia Brain Monitoring and Lidocaine, run by University of Padova at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Anesthesia Brain Monitoring, Lidocaine
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 18 Nov 2023to 15 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Adult, Older adult
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, and Lidocaine bolus and infusion for postoperative pain will be included.
Who may be able to join
- 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.
Who cannot join
- Neurological disease
- Psychiatric disease
- Obesity
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)
Read the 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.
- Conditions
- Anesthesia Brain Monitoring, Lidocaine
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Nov 2023
- Primary completion1 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Brain MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Linassi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135688
- Sponsor's protocol ID
- LidoMAST
- Status last verified
- Apr 2024
- First submitted
- 12 Nov 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Linassi F, Carron M, Zanatta P, Aydin D, Spano L, Rizzetto C, Polesello L, Schneider G, Bonhomme V, Kreuzer M. Effects of lidocaine bolus and infusion on neuromonitoring by bispectral index (BIS(R)), electroencephalogram periodic and aperiodic activity, and Surgical Pleth Index(R) during propofol-remifentanil anaesthesia: a single-centre prospective observational study. Br J Anaesth. 2026 Sep 22:S0007-0912(26)00625-2. doi: 10.1016/j.bja.2026.07.058. Online ahead of print.
PubMed 42772975
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06135688
- Acronym / sponsor ID
- LidoMAST
- Conditions
- Anesthesia Brain Monitoring, Lidocaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 18 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, and Lidocaine bolus and infusion for postoperative pain will be included.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Neurological disease
- Psychiatric disease
- Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 42772975Linassi F, Carron M, Zanatta P, Aydin D, Spano L, Rizzetto C, Polesello L, Schneider G, Bonhomme V, Kreuzer M. Effects of lidocaine bolus and infusion on neuromonitoring by bispectral index (BIS(R)), electroencephalogram periodic and aperiodic activity, and Surgical Pleth Index(R) during propofol-remifentanil anaesthesia: a single-centre prospective observational study. Br J Anaesth. 2026 Sep 22:S0007-0912(26)00625-2. doi: 10.1016/j.bja.2026.07.058. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Brain Monitoring and Lidocaine, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.