Effect of Ketamine Infusion on BIS Values

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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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

Conditions
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Anesthesia Brain Monitoring, Ketamine

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CeK 0.1<br>Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.1 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated. | Drug: Ketamine<br>* 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.<br>|
| CeK 0.2<br>Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.2 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated. | Drug: Ketamine<br>* 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.<br>|
| CeK 0.4<br>Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.4 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated. | Drug: Ketamine<br>* 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.<br>|
| CeK 0.6<br>Data about Continuous infusion with Concentration at the effector site of Ketamine (CeK) set (at anesthesiologist's discretion) at 0.1 ug/ml for at least 30 minute and BIS during a propofol-remifentanil general anesthesia will be correlated. | Drug: Ketamine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |