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NCT05799729 Clinical Trial

Effect of Ketamine Infusion on BIS Values

Ketamine Clinical Trial

Official title:
Correlation Between Concentration at the Effector Site of Continuous Infusion 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 NCT05799729
Other study ID # KetainfusionMAST
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date September 30, 2023

Study information
Verified date October 2023
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim of this trial is to define if Concentration at the effector site (Ce) of Ketamine, during a continuous infusion and 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 during a continuous infusion. Authors want to analyze this correlation during general anaesthesia conducted using Propofol, ketamine and remifentanil. All of these drugs will be delivered with Target-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil and Domino for Ketamine). Ketamine will be observationally set at anaesthesiologist's discretion, but only CeK 0.1, 0.2, 0.4 and 0.6 for at least 30 minutes will be considered for analysis.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Undergo general anaesthesia with Targeted Controlled Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model) Exclusion Criteria: - Neurological disease - Psychiatric disease - Benzodiazepines intake - Obesity

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ketamine
CeK will be set at anesthesiologist's discretion. Only patients with continuous infusion of CeK 0.1, 0.2, 0.4 or 0.6 for at least 30 minutes will be considered.

Locations
Country Name City State
Italy Treviso Regional Hospital 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 Data about Drugs concentration and BIS during general anaesthesia will be collected, in particular BIS and TCI Ketamine values during all the duration of anesthesia, from the start of ketamine infusion until the stop of ketamine infusion(30minutes)
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