Effect of Rocuronium on BIS Values

Sponsor

University of Padova (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05681611

Collaborator

(none)

Enrollment

2.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer General Anaesthesia	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 Design

Study Type:

Observational

Anticipated Enrollment :

8 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 3, 2023

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Federico Linassi, MD. Anaesthesiologist at Treviso Regional Hospital, University of Padova

ClinicalTrials.gov Identifier:

NCT05681611

Other Study ID Numbers:

RocuMAST

First Posted:

Jan 12, 2023

Last Update Posted:

Jan 12, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rocuronium

Study Results

No Results Posted as of Jan 12, 2023