Effect of Ketamine Infusion on BIS Values

October 18, 2023 updated by: Federico Linassi, University of Padova

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TV
      • Treviso, TV, Italy, 31100
        • Treviso Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Authors will recruit patients who will undergo breast oncologic surgery and anesthetized with TIVA-TCI propofol,remifentanil and ketamine anesthesia.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Concentration at the effector site of Ketamine and BIS values
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KetainfusionMAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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