NCT06135688

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

November 12, 2023

Last Update Submit

April 24, 2024

Conditions

Anesthesia Brain MonitoringLidocaine

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Neurological disease
  • Psychiatric disease
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, principal investigator

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 18, 2023

Study Start

November 18, 2023

Primary Completion

March 1, 2024

Study Completion

March 15, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

IT(1)