NCT05681611

Brief Summary

Aim of this trial is to define if Trend of Four (TOF) values after a bolus of rocuronium is correlated with Bispectral Index BIS values during standard general anaesthesia for breast surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

November 24, 2022

Last Update Submit

October 18, 2023

Conditions

Breast CancerGeneral Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Correlation between Trend of Four (TOF) and Bispectral Index (BIS) values

    Discover if there is linear correlation between TOF values (utilized for curarization monitoring) and BIS values (utilized for deep of hypnosis monitoring) during standard general anaesthesia conducted with Propofol and remifentanil with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia

    60 minutes after rocuronium bolus

Interventions

RocuroniumDRUG

Rocuronium bolus was administered, according to our protocol, to facilitate surgery and ventilation.

Eligibility Criteria

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

Fe-male patients undergoing breast oncologic surgery

You may qualify if:

  • Undergo General Anaesthesia with Propofol and Remifentanil, and necessity of curarization with Rocuronium for surgical or ventilatory reasons.

You may not qualify if:

  • Neurological disease
  • Psychiatric disease
  • Benzodiazepines praemedication
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULSS2

Treviso, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Anaesthesiologist at Treviso Regional Hospital

Study Record Dates

First Submitted

November 24, 2022

First Posted

January 12, 2023

Study Start

March 3, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations

IT(1)