Effect of Ketamine on BIS Values
Correlation Between Concentration at the Effector Site of Ketamine (Calculated With DOMINO Pump) and Bispectral Index Values During General Anaesthesia for Breast Surgery.
1 other identifier
observational
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedStudy Start
First participant enrolled
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedJune 13, 2023
June 1, 2023
10 months
March 10, 2022
June 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
Interventions
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)
Eligibility Criteria
Adult Women undergoing breast surgery for breast cancer
You may qualify if:
- Undergo gneral anaesthsia with Targted Controlld Infusion of Ketamine (Domino model), Propofol (Schnider model) and Remifentanil (Minto model)
You may not qualify if:
- Neurological disease
- Psychiatric disease
- Benzodiazepiones absuntion
- Obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ULSS 2 Marca Trevigiana
Treviso, Tv, 31100, Italy
Related Publications (1)
Linassi F, Troyas C, Kreuzer M, Spano L, Burelli P, Schneider G, Zanatta P, Carron M. Effect of Ketamine on the Bispectral Index, Spectral Edge Frequency, and Surgical Pleth Index During Propofol-Remifentanil Anesthesia: An Observational Prospective Trial. Anesth Analg. 2025 Jun 1;140(6):1276-1285. doi: 10.1213/ANE.0000000000007255. Epub 2024 Nov 1.
PMID: 39485729DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 21, 2022
Study Start
March 31, 2022
Primary Completion
January 15, 2023
Study Completion
January 30, 2023
Last Updated
June 13, 2023
Record last verified: 2023-06