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NCT06344858: Keta-ANI
Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI
trial testing Ketamine in Analgesia in 20 participants. Completed in 1 August 2024.
1 August 2024
Quick facts
| Lead sponsor | Pontificia Universidad Catolica de Chile |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 30 April 2024 |
| Primary completion | 1 August 2024 |
| Estimated completion | 1 August 2024 |
| Sites | 1 location across Chile |
Drugs / interventions tested
- Ketamine (ketamine) — full drug profile →
Conditions studied
- Analgesia — all drugs for Analgesia →
- Ketamine — all drugs for Ketamine →
- Pharmacokinetic — all drugs for Pharmacokinetic →
Sponsor
Pontificia Universidad Catolica de Chile — full company profile →
Who can join
Adults 40 to 80, any sex, with Analgesia or Ketamine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06344858
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Pontificia Universidad Catolica de Chile trials
Trials by the same sponsor.
- NCT07396129 — Assessing the Efficacy of a High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06344858 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pontificia Universidad Catolica de Chile
- Last refreshed: 22 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06344858.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing