Effect of Ketamine on BIS Values

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ClinicalTrials.gov Identifier: NCT05288764

Recruitment Status : Recruiting

First Posted : March 21, 2022

Last Update Posted : March 31, 2022

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Sponsor:

Information provided by (Responsible Party):

Federico Linassi, University of Padova

Tracking Information

First Submitted Date

March 10, 2022

First Posted Date

March 21, 2022

Last Update Posted Date

March 31, 2022

Actual Study Start Date

November 1, 2020

Estimated Primary Completion Date

April 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Correlation between Concentration at the effector site of Ketamine and BIS values [ Time Frame: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Ketamine values during all the duration of anesthesia, form the start of ketamine bolus until the emergence from anesthesia ]

Discover if there is linear correlation between Concentration at the effector site of Ketamine and BIS values during standard general anaesthesia conducted with Propofol, remifenatnil and ketamine delivered with targeted controlled infusion pumps, usually adopted in our Hospital to delivery general anaesthesia

Original Primary Outcome Measures

Correlation between Concentration at the effector site of Ketamine and BIS values [ Time Frame: We will collected data about Drugs concentration and BIS values during general anaesthesia ]

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Effect of Ketamine on BIS Values

Official Title

Correlation Between Concentration at the Effector Site of Ketamine (Calculated With DOMINO Pump) and Bispectral Index Values During General Anaesthesia for Breast Surgery.

Brief Summary

Aim of this trial is to define if Concentration at the effector site (Ce) of Ketamine, calculated with DOMINO model infusion pump are correlated with Bispectral Index BIS values during general anaesthesia for breast surgery.

Detailed Description

Correlation between Concentration at the effector site (Ce) of Ketamine and Bispectral Index (BIS) values during general anaesthesia for breast surgery has not been defined yet.

We want to analyze this correlation during general anaesthesia conducted using Propofol, ketamine and remifentanil. All of these drugs will be delivered with Targeted-ControlledInfusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil and Domino for Ketamine).

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adult Women undergoing breast surgery for breast cancer

Condition

Anesthesia Brain Monitoring
Ketamine

Intervention

Device: Bispectral Index

Comparing Bispectral index values (usually adopted during general anaesthesia monitoring) to Ketamine concenetration at the effector site calculated with Domino model pump (usually adopted for Ketamine infusion during general anaesthesia)

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

May 15, 2022

Estimated Primary Completion Date

April 15, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Undergo gneral anaesthsia with Targted Controlld Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

Neurological disease
Psychiatric disease
Benzodiazepiones absuntion
Obesity

Sex/Gender

Sexes Eligible for Study:	Female
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Women undergoing brast cancer surgery

Ages

18 Years to 90 Years (Adult, Older Adult)

Accepts Healthy Volunteers

Not Provided

Contacts

Listed Location Countries

Italy

Removed Location Countries

Administrative Information

NCT Number

NCT05288764

Other Study ID Numbers

KetaMAST

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Not Provided

Current Responsible Party

Federico Linassi, University of Padova

Original Responsible Party

Same as current

Current Study Sponsor

University of Padova

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Not Provided

PRS Account

University of Padova

Verification Date

March 2022

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