Analgesia Clinical Trial
— Keta-ANIOfficial title:
Characterization of the Temporal Profile of the Anti- Nociceptive Effect of an Intravenous Ketamine Bolus Using the Nociception Analgesia Index (ANI)
NCT number | NCT06344858 |
Other study ID # | 124/2021 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 30, 2024 |
Est. completion date | December 31, 2024 |
Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - Elective surgery with general anaesthesia - Without premedication - ASA I, II or III Exclusion Criteria: - Body weight greater than 120% of ideal weight - Ingestion of sedatives of short or long action in the 48 hours before surgery - People with a history of adverse effects to the drug under study |
Country | Name | City | State |
---|---|---|---|
Chile | Pontificia Universidad Catolica de Chile | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure ANI values after ketamine bolus dose administration. | The observed effect of ketamine is measured with the ANI monitor index in each patient (outcome is ANI values [ANI Units]) | Every 6 seconds for 5 minutes after ketamine bolus | |
Primary | To determine the time maximum predicted concentrations in each patient | The time from the start of ketamine administration until the maximum predicted ketamine plasma concentrations value will be determined in each patient (mg/L). | Every 6 seconds for 5 minutes after ketamine bolus | |
Primary | To determine the time to maximum effect of a bolus dose of ketamine | The time from the start of ketamine administration until the maximum ANI index value will be determined in each patient (ANI Values/minutes) | Every 6 seconds for 5 minutes after ketamine bolus | |
Primary | To predict ketamine plasma concentrations values after ketamine bolus | The expected maximum plasma concentrations mg/L. Wil be estimated using the pharmacokinetic parameters of Domino knowing the administered dose (0.1 mg/Kg). | Every 6 seconds for 5 minutes after ketamine bolus | |
Primary | To calculate the difference between the time of maximum ANI effect | With the time (minutes) maximum predicted concentrations and the ketamine plasma concentrations (mg/mL) | At the minute of maximum effect | |
Secondary | Patient weight | The patient's weight will be measured prior to the administration of the ketamine bolus, which will be described in kg. | Once before the procedure |
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