Effect of Ketamine Infusion on BIS Values

Sponsor

University of Padova (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799729

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Brain Monitoring Ketamine	Drug: Ketamine

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 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
CeK 0.1 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 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.
CeK 0.2 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 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.
CeK 0.4 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 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.
CeK 0.6 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 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.

Outcome Measures

Primary Outcome Measures

Correlation between Concentration at the effector site of Ketamine and BIS values [Data about Drugs concentration and BIS values during general anaesthesia will be collected, in particular BIS and TCI Ketamine values during all the duration of anesthesia, form the start of ketamine infusion until the stop of ketamine infusion (30 min)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Federico Linassi, MD, Principal investigator, University of Padova

ClinicalTrials.gov Identifier:

NCT05799729

Other Study ID Numbers:

KetainfusionMAST

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ketamine

Study Results

No Results Posted as of Apr 5, 2023