NCT03682198

Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neurosurgery
• Elective Craniotomy
• General Anaesthesia

Interventions

Type	Name	Description
DEVICE	NIRS measurements on skin, skull and dura	During a neurosurgical procedure, we will measure the brain oxygenation with a NIRS-electrode, first on forehead skin, then on the skull and finally directly on dura.
DRUG	Phenylephrine's effect on brain oxygenation	With a Clark-electrode (Licox(R)) in the white matter and a NIRS-electrode on the forehead skin, we will give a small dose (0.1 mg iv.) Phenylephrine.
DRUG	Normal vs. high inspired oxygen	By the end of the neurosurgical procedure, still with a Clark-electrode in the white matter and a NIRS-electrode on forehead skin, we will change the inspired oxygen fraction from 0.3 to 0.8.

Timeline

• Start date: 2018-09-24
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2018-09-24
• Last updated: 2020-11-03

Locations

1 site across 1 country: Denmark