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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05681611
Other study ID # RocuMAST
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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