Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI

NCT06344858 | Completed DMC

• 1 other identifier: 124/2021
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia; Ketamine; Pharmacokinetic

Keywords

Ketamine; Analgesia; Target controlled infusion

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Patient weight

  Once before the procedure

Study Arms (1)

Ketamine

In the preoperative room a vein of the forearm with preriferic access #18 will be established for the administration of general intravenous anesthesia and intraoperative fluids. In the operating room, after routine monitoring (Heart Rate, Non-Invasive Blood Pressure, Oxygen Saturometry), the sensor of the Nociception Analgesia Index (ANI) monitor will be installed from the right chest to the left 5th intercostal space. Wait XX time for calibration and capture of the electrocardiographic signal. The ANI value shall initially be measured and shall be considered as the reference value. Inject 0.1 mg/kg of ketamine (1 mg/ml) once, then inject 5 ml of physiological saline at the same rate. The time from ketamine administration until the ANI index rose above 50 (minimum appropriate nociception value) shall be recorded every 6 seconds.

Drug: Ketamine

Interventions

Ketamine DRUG

One bolus of ketammine

Also known as: Analgesia using ketamine

Ketamine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery with general anaesthesia.

You may qualify if:

• Elective surgery with general anaesthesia
• Without premedication
• ASA I, II or III

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 450881, Chile

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Luis I Cortinez, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: April 3, 2024
• Study Start: April 30, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CL (1)