Effect of Rocuronium on BIS Values

NCT ID: NCT05681611

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-03

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer General Anaesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Rocuronium

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Federico Linassi

MD. Anaesthesiologist at Treviso Regional Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ULSS2

Treviso, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RocuMAST

Identifier Type: -

Identifier Source: org_study_id

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