NCT06351072

Brief Summary

qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia. No trials have compared them, so with this trial authors want to explore the correlations between them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

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
completed

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 25, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 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

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

March 25, 2024

Last Update Submit

October 21, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Correlation between qNOX and ANI values

    qNOX and ANI values will be compared to check the correspondance in evaluting analgesia level

    qNOX, ANI, pupoillometry values, propofol and remifentanil concentration during induction, intubation, after post-tetanic count at the trend-of-four and maintenance phase of general anesthesia detected with target controlled inusion will be paired.

Secondary Outcomes (2)

  • Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain

    qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative pain, evalued with NRS score after 24 hours

  • Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium

    qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative delirium, evaluated with CAM and 4AT score after 24 hours

Eligibility Criteria

Age18 Years - 90 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 will be recruited

You may qualify if:

  • Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and remifentanil (Eleveld model)

You may not qualify if:

  • Neurological disease
  • Psychiatric disease
  • Obesity
  • Regional anesthesia performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 8, 2024

Study Start

April 2, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

October 24, 2024

Record last verified: 2024-10

Locations

IT(1)