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NCT03716453
Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index
NA trial testing Standard protocol in Postoperative Pain in 60 participants. Completed in 30 August 2019.
31 May 2019
Quick facts
| Lead sponsor | Khon Kaen University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 October 2018 |
| Primary completion | 31 May 2019 |
| Estimated completion | 30 August 2019 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Standard protocol — full drug profile →
- ANI protocol
Conditions studied
- Postoperative Pain — all drugs for Postoperative Pain →
- Postoperative Complications — all drugs for Postoperative Complications →
Sponsor
Khon Kaen University
Who can join
Adults 18 to 80, female only, with Postoperative Pain or Postoperative Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Balanced anesthesia needs optimization of hypnotic, relaxant, and narcotic. Administration of hypnotic drugs can be monitored by bispectral index score (BIS), while the dosage of muscle relaxants can be guided by train-of four (TOF). However, administration of narcotics lacks objective monitor. Overdosage of narcotic may lead to delayed awakening, while underdosage may lead to high degree of postoperative pain. Recently, there is a monitor, Analgesic Nociceptive Index (ANI) monitor, designed to guide the administration of narcotics. There are many descriptive studies supporting the correlation of ANI score and pain score but there are still very few randomized control studies which report the efficacy of ANI in clinical practice.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients.
Tribuddharat S, Sathitkarnmanee T, Sukhong P, Thananun M, et al · · 2021 · cited 12× · PMID 33581721 · DOI 10.1186/s12871-021-01272-2
Verify or expand the search:
- PubMed search for NCT03716453
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Khon Kaen University trials
Trials by the same sponsor.
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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 NCT03716453 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Khon Kaen University
- Last refreshed: 27 November 2019
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/NCT03716453.
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