Effect of Ketamine on BIS Values

Ketamine Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05288764
• Other study ID #: KetaMAST
• Status: Completed
• Start date: March 31, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: June 2023
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 30, 2023
• Est. primary completion date: January 15, 2023
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• 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)

Locations

Country	Name	City	State
Italy	ULSS 2 Marca Trevigiana	Treviso	Tv

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 Concentration at the effector site of Ketamine and BIS values	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	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