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Effect of Ketamine Infusion on BIS Values

U

University of Padova

Status

Completed

Conditions

Anesthesia Brain Monitoring
Ketamine

Treatments

Drug: Ketamine

Study type

Observational

Funder types

Other

Identifiers

NCT05799729
KetainfusionMAST

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 4 patient groups

CeK 0.1
Description:
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.
Treatment:
Drug: Ketamine
CeK 0.2
Description:
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.
Treatment:
Drug: Ketamine
CeK 0.4
Description:
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.
Treatment:
Drug: Ketamine
CeK 0.6
Description:
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.
Treatment:
Drug: Ketamine

Trial contacts and locations

1

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Central trial contact

Federico Linassi, MD

Data sourced from clinicaltrials.gov

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