Effect of Rocuronium on BIS Values

Correlation Between Trend of Four Values and Bispectral Index Values During General Anaesthesia for Breast Surgery.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05681611

Enrollment

Registered

2023-01-12

Start date

2023-03-03

Completion date

2023-09-30

Last updated

2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, General Anaesthesia

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.

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.

Interventions

DRUGRocuronium

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria

* Neurological disease * Psychiatric disease * Benzodiazepines praemedication * Obesity

Design outcomes

Primary

Measure	Time frame	Description
Correlation between Trend of Four (TOF) and Bispectral Index (BIS) values	60 minutes after rocuronium bolus	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026