Last reviewed · How we verify
NCT03846765: NIRS continu
Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS).
Phase 4 trial testing Phenylephrine in Nfuence of Vasoactive Medication on Spinal Oxygenation in 36 participants. Completed in 10 November 2022.
22 May 2021
Quick facts
| Lead sponsor | University Hospital, Ghent |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 36 |
| Start date | 4 July 2019 |
| Primary completion | 22 May 2021 |
| Estimated completion | 10 November 2022 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Phenylephrine (phenylephrine) — full drug profile →
- Dobutamine (DOBUTAMINE) — full drug profile →
Conditions studied
- Nfuence of Vasoactive Medication on Spinal Oxygenation — all drugs for Nfuence of Vasoactive Medication on Spinal Oxygenation →
Sponsor
University Hospital, Ghent
Who can join
18 and older, any sex, with Nfuence of Vasoactive Medication on Spinal Oxygenation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To assess the effect of hemodynamic supportive medication on spinal vasculature, patients scheduled for arterial dilation of the lower limb were chosen as our study population. The spinal cord perfusion is not compromised in these patients, however, most patients suffer from hypotension during this kind of surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, continuous administration of vasoactive medication (phenylephrine or dobutamine) is often required in order to increase blood pressure. The aim of our study is to evaluate the effect of a continuous administration of phenylephrine or dobutamine on the spinal oxygenation, assessed by NIRS.
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 NCT03846765
- 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 NCT03846765 (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 University Hospital, Ghent
- Last refreshed: 12 December 2022
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/NCT03846765.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing