Effect of Rocuronium on BIS Values

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05681611
• Other study ID #: RocuMAST
• Status: Completed
• Start date: March 3, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• General Anaesthesia

Intervention

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

Locations

Country	Name	City	State
Italy	ULSS2	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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