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NCT04519203
The Use of Surgical Pleth Index in Guiding Anesthesia in Gastroenterological Surgery
NA trial testing SPI in Intraoperative Complications in 80 participants. Completed in 1 November 2021.
1 November 2021
Quick facts
| Lead sponsor | Tampere University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 9 September 2020 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 November 2021 |
| Sites | 1 location across Finland |
Drugs / interventions tested
- SPI
- Standard
Conditions studied
- Intraoperative Complications — all drugs for Intraoperative Complications →
- Intraoperative Hypotension — all drugs for Intraoperative Hypotension →
- Intraoperative Hypertension — all drugs for Intraoperative Hypertension →
Sponsor
Tampere University Hospital
Who can join
50 and older, any sex, with Intraoperative Complications or Intraoperative Hypotension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Surgical Pleth Index (SPI) is an intraoperative monitor aimed into detection of nociception and guidance of intraoperative opioid administration. Using such a device opioid administration could be potentially optimized during intraoperative period. this study will aim to show whether SPI could be used to reduce unwanted events and lower opioid consumption in gastroenterological surgery. The study will be blinded and randomized including two study arms with either SPI monitoring included or standard monitoring alone.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The use of the surgical pleth index to guide anaesthesia in gastroenterological surgery: a randomised controlled study.
Bergman T, Kalliomäki ML, Särkelä M, Harju J. · · 2025 · PMID 39831949 · DOI 10.1007/s10877-025-01262-6
Verify or expand the search:
- PubMed search for NCT04519203
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04519203 (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 Tampere University Hospital
- Last refreshed: 25 November 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/NCT04519203.
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