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).
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
Dosing
Integration
Study Arms & Interventions
Ketamine
experimentalSingle IV ketamine bolus with ANI monitoring to characterise anti-nociceptive time profile.
Interventions
- Ketamine0.1 mg/kgvia 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
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 Details
- StatusCompleted
- PhasePhase NA
- Typeobservational
- DesignNon-randomized
- Target Enrollment20 participants
- TimelineStart: 2024-03-30End: 2024-12-31
- Compound
- Topic