Effect of Rocuronium on BIS Values

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; General Anaesthesia
• Intervention / Treatment: Drug: Rocuronium

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• Italy
  • Treviso, Italy
    • ULSS2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Fe-male patients undergoing breast oncologic surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: RocuMAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No