Effect of Ketamine on BIS Values

NCT ID: NCT05288764

Last Updated: 2023-06-13

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

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-01-30

Brief Summary

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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

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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).

Conditions

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Anesthesia Brain Monitoring Ketamine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ULSS 2 Marca Trevigiana

Treviso, Tv, Italy

Site Status

Countries

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Italy

References

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Linassi F, Troyas C, Kreuzer M, Spano L, Burelli P, Schneider G, Zanatta P, Carron M. Effect of Ketamine on the Bispectral Index, Spectral Edge Frequency, and Surgical Pleth Index During Propofol-Remifentanil Anesthesia: An Observational Prospective Trial. Anesth Analg. 2025 Jun 1;140(6):1276-1285. doi: 10.1213/ANE.0000000000007255. Epub 2024 Nov 1.

Reference Type DERIVED
PMID: 39485729 (View on PubMed)

Other Identifiers

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KetaMAST

Identifier Type: -

Identifier Source: org_study_id

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