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CompletedNCT05681611Updated Oct 19, 2023

Effect of Rocuronium on BIS Values

An observational study in Breast Cancer and General Anaesthesia, sponsored by University of Padova. Completed at 1 site in Italy. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by University of Padova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the detailed description

Rocuronium. a curarizing agent, has been shown to decrease Bispectral Index (BIS) in awake volunteers.

However, correlation between Trend of Four (TOF) values after a bolus of rocuronium and BIS values during general anaesthesia for breast surgery has not been defined yet.

Investigators want to analyze this correlation during general anaesthesia conducted using Propofol and remifentanil. All of these drugs will be delivered with Targeted-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil), commonly used to deliver general anaesthesia. At stable anaesthesia maintenance, if requested for surgical (ie more muscle relaxation) or anesthesiological reasons (i.e. avoid air insufflation) a standard Rocuronium bolus (0.6 mg/kg) was given. In these case, with rocuronium bolus justified by clinical reasons, authors will observationally record the BIS values and the TOF values.

02

Conditions studied

  • Breast Cancer
  • General Anaesthesia
03

In context

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Fe-male patients undergoing breast oncologic surgery

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Neurological disease
  • Psychiatric disease
  • Benzodiazepines praemedication
  • Obesity
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No

Interventions

  • DrugRocuronium

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

06

What researchers measure

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

    Time frame: 60 minutes after rocuronium bolus

07

Study locations

1 site
  • ULSS2
    Treviso, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05681611
Lead sponsor
University of Padova
Responsible party
Federico Linassi (MD. Anaesthesiologist at Treviso Regional Hospital, University of Padova) — Principal investigator
First posted
Jan 12, 2023
Start date
Mar 3, 2023
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023
Last update
Oct 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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