Skip to main content
OpenTrials
Completed

NCT Number: NCT05681611

Effect of Rocuronium on BIS Values

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms General Anaesthesia Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

ULSS2

Treviso, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

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

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.