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NCT03682198
Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
NA trial testing NIRS measurements on skin, skull and dura in Neurosurgery in 18 participants. Completed in 1 October 2020.
1 October 2020
Quick facts
| Lead sponsor | University Hospital Bispebjerg and Frederiksberg |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 18 |
| Start date | 24 September 2018 |
| Primary completion | 1 October 2020 |
| Estimated completion | 1 October 2020 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- NIRS measurements on skin, skull and dura
- Phenylephrine's effect on brain oxygenation — full drug profile →
- Normal vs. high inspired oxygen — full drug profile →
Conditions studied
- Neurosurgery — all drugs for Neurosurgery →
- Elective Craniotomy — all drugs for Elective Craniotomy →
- General Anaesthesia — all drugs for General Anaesthesia →
Sponsor
University Hospital Bispebjerg and Frederiksberg
Who can join
18 and older, any sex, with Neurosurgery or Elective Craniotomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and a NIRS-electrode, to see how Phenylephrine affects these measurements. In the third substudy, the brain oxygenations' (NIRS and Licox) response to an inspired oxygen fraction of 0.30 vs. 0.80 is investigated.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Impact of hyperoxia and phenylephrine on cerebral oxygenation: An experimental clinical study.
Pedersen SS, Meyhoff CS, Olsen MH, Stisen ZR, et al · · 2023 · cited 6× · PMID 36112064 · DOI 10.1111/aas.14149
Verify or expand the search:
- PubMed search for NCT03682198
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital Bispebjerg and Frederiksberg 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 NCT03682198 (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 University Hospital Bispebjerg and Frederiksberg
- Last refreshed: 3 November 2020
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/NCT03682198.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing