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

University Hospital Bispebjerg and Frederiksberg

Status: Completed

Conditions: Elective Craniotomy; General Anaesthesia; Neurosurgery

Treatments: Device: NIRS measurements on skin, skull and dura; Drug: Normal vs. high inspired oxygen; Drug: Phenylephrine's effect on brain oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT03682198

Neuro-Ox 2018

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (>18 years) patients
• Elective craniotomy

Exclusion criteria

• Repeat craniotomy
• Preoperative hypotension (defined as systolic blood pressure below 110 mmHg)
• Preoperative hypoxia (defined as peripheral oxygen saturation (SpO2) < 90% without oxygen supplementation before surgery)
• No negative pregnancy test for women <50 years.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

One strategy for all enrolled patients:

Other group

Description:

All patients will participate in three substudies, in which they also act as controls, with exposure to the same three interventions: 1) NIRS-measurement on skin, skull and dura, 2) Phenylephrine 0.1 mg iv., and 3) inspired oxygen fraction of 0.3 vs. 0.8

Treatment:

Drug: Phenylephrine's effect on brain oxygenation

Drug: Normal vs. high inspired oxygen

Device: NIRS measurements on skin, skull and dura