Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Ketamine on BIS Values

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05288764
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Federico Linassi, University of Padova

Tracking Information
First Submitted Date March 10, 2022
First Posted Date March 21, 2022
Last Update Posted Date March 31, 2022
Actual Study Start Date November 1, 2020
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2022)
Correlation between Concentration at the effector site of Ketamine and BIS values [ Time Frame: We will collected data about Drugs concentration and BIS values during general anaesthesia. We will collect BIS and TCI Ketamine values during all the duration of anesthesia, form the start of ketamine bolus until the emergence from anesthesia ]
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
Original Primary Outcome Measures
 (submitted: March 10, 2022)
Correlation between Concentration at the effector site of Ketamine and BIS values [ Time Frame: We will collected data about Drugs concentration and BIS values during general anaesthesia ]
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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Ketamine on BIS Values
Official Title Correlation Between Concentration at the Effector Site of Ketamine (Calculated With DOMINO Pump) and Bispectral Index Values During General Anaesthesia for Breast Surgery.
Brief Summary Aim of this trial is to define if Concentration at the effector site (Ce) of Ketamine, calculated with DOMINO model infusion pump are correlated with Bispectral Index BIS values during general anaesthesia for breast surgery.
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.

We want to analyze this correlation during general anaesthesia conducted using Propofol, ketamine and remifentanil. All of these drugs will be delivered with Targeted-ControlledInfusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil and Domino for Ketamine).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult Women undergoing breast surgery for breast cancer
Condition
  • Anesthesia Brain Monitoring
  • Ketamine
Intervention Device: Bispectral Index
Comparing Bispectral index values (usually adopted during general anaesthesia monitoring) to Ketamine concenetration at the effector site calculated with Domino model pump (usually adopted for Ketamine infusion during general anaesthesia)
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 10, 2022)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 15, 2022
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Undergo gneral anaesthsia with Targted Controlld Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

  • Neurological disease
  • Psychiatric disease
  • Benzodiazepiones absuntion
  • Obesity
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women undergoing brast cancer surgery
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT05288764
Other Study ID Numbers KetaMAST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Federico Linassi, University of Padova
Original Responsible Party Same as current
Current Study Sponsor University of Padova
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Padova
Verification Date March 2022