NCT06349681

Brief Summary

CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia. It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

March 24, 2024

Last Update Submit

April 24, 2024

Conditions

Anesthesia Brain Monitoring

Keywords

Anesthesia brain MonitoringTIVA-TCICONOX

Outcome Measures

Primary Outcomes (1)

  • Correlation between qCON and qNOX

    qCON and qNOX values from CONOX monitor will be compared

    CONOX values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery

Secondary Outcomes (2)

  • Correlation between qCON and concentrations of Propofol(CeP)

    CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery

  • Correlation between qNOX and concentrations of Remifentanil (CeR)

    CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
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 will be recruited

You may qualify if:

  • Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model) and CONOX monitoring

You may not qualify if:

  • Neurological disease
  • Psychiatric disease
  • Obesity
  • Locoregional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

RECRUITING

Central Study Contacts

Federico Linassi, MD

CONTACT

0422322440federico.linassi@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 5, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

IT(1)