Effect of Ketamine on BIS Values

Completed

• Conditions: Ketamine; Anesthesia Brain Monitoring

• Registration Number: NCT05288764
• Lead Sponsor: University of Padova

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 Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-21
• Study Start: 2022-03-31
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-10
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ULSS 2 Marca Trevigiana; 🇮🇹 Treviso, Tv, Italy