Effect of Ketamine on BIS Values

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05288764

Enrollment

Registered

2022-03-21

Start date

2022-03-31

Completion date

2023-01-30

Last updated

2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Brain Monitoring, Ketamine

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).

Interventions

DEVICEBispectral 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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between Concentration at the effector site of Ketamine and BIS values	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026