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

NCT03682198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-11-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682198 on ClinicalTrials.gov