Clinical TrialChronic PainKetamineCompleted

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

This observational cohort study will characterise the temporal profile of the anti-nociceptive effect of an intravenous ketamine bolus using the Nociception Analgesia Index (ANI).

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Target Enrollment
20 participants
Study Type
Phase NA observational
Design
Non-randomized

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Compound research: KetamineTopic research: Chronic PainResearch in Chile

Detailed Description

This prospective observational cohort (n=20) will record ANI continuously around a single IV ketamine bolus in patients scheduled for elective surgery under general anaesthesia to describe the time course of the anti-nociceptive effect.

PKPD modelling will use the Domino pharmacokinetic model and an Emax link model with a ke0 to relate predicted effect-site concentrations to ANI changes; analyses performed with NONMEM. ANI will be sampled every 6 seconds for 5 minutes after the bolus.

Study Protocol

Preparation

sessions

Dosing

1 sessions
5 min each

Integration

sessions

Study Arms & Interventions

Ketamine 7 mg/70 kg

experimental

Single IV ketamine bolus with ANI monitoring to characterise anti-nociceptive time profile.

Interventions

  • Ketamine0.1 mg/kg
    via IV• single dose• 1 doses total

    1 mg/ml bolus; followed by 5 ml saline flush; ANI recorded every 6 seconds for 5 minutes.

Participants

Ages
40 – 80
Sexes
Male & Female

Inclusion Criteria

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

Exclusion Criteria

  • 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

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2024-04-30
    End: 2024-08-01
  • Compound
    Ketamine
  • Topic
    Chronic Pain

Study Team

Sponsors & Collaborators

Locations

Pontificia Universidad Catolica de Chile — Santiago, Santiago Metropolitan, Chile

Recent activity

  • CompletedCharacterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With A… (NCT06344858, ketamine)
  • StartedCharacterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With A… (NCT06344858, ketamine)

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