Clinical trial

Characterization of the Temporal Profile of the Anti- Nociceptive Effect of an Intravenous Ketamine Bolus Using the Nociception Analgesia Index (ANI)

Name

124/2021

Description

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.

Trial arms

Trial start

2024-04-30

Estimated PCD

2024-08-31

Trial end

2024-12-31

Status

Recruiting

Treatment

Ketamine

One bolus of ketammine

Arms:

Ketamine

Other names:

Analgesia using ketamine

Size

Primary endpoint

To measure ANI values after ketamine bolus dose administration.

Every 6 seconds for 5 minutes after ketamine bolus

To determine the time maximum predicted concentrations in each patient

Every 6 seconds for 5 minutes after ketamine bolus

To determine the time to maximum effect of a bolus dose of ketamine

Every 6 seconds for 5 minutes after ketamine bolus

To predict ketamine plasma concentrations values after ketamine bolus

Every 6 seconds for 5 minutes after ketamine bolus

To calculate the difference between the time of maximum ANI effect

At the minute of maximum effect

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Day', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-29

1 organization

1 drug

3 indications

Organization

Pontificia Universidad Catolica de Chile

Drug

Indication

Indication

Indication