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Completed

NCT Number: NCT03682198

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

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.

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Key information

Conditions

Neurosurgery Elective Craniotomy General Anaesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIRS measurements on skin, skull and dura

Device

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.

Phenylephrine's effect on brain oxygenation

Drug

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.

Normal vs. high inspired oxygen

Drug

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.

Primary outcomes

  1. ScO2 (NIRS-measured cerebral oxygen saturation)

    Time frame: During surgical procedure

    Difference in ScO2 between dura and skin (Primary analysis for substudy 1)

Secondary outcomes

  1. PBrO2 (Partial pressure of brain tissue oxygen)

    Time frame: During surgical procedure

    Cerebral oxygenation, measured by a Clark-electrode (Licox (R)) (Primary outcome measure for substudy 2)

  2. PBrO2 (Partial pressure of brain tissue oxygen)

    Time frame: 'Normoxia' is induced with FiO2 = 0.30 for 5 minutes, and then changed to 'Hyperoxia' with FiO2 = 0.80 for the subsequent 5 minutes, while registering the Licox-signal.

    Cerebral oxygenation during inspired oxygen fraction 0.80 vs. 0.30 (Primary outcome for substudy 3)

  3. ScO2 (NIRS-measured cerebral oxygen saturation)

    Time frame: Measurements will be performed as the surgeon exposes the skull.

    Difference in ScO2 between dura and skull, and between skull and skin (this will be the secondary analyses of substudy 1)

  4. ScO2 (NIRS-measured cerebral oxygenation)

    Time frame: NIRS signal is obtained continuously during the Phenylephrine intervention

    NIRS-signal during Phenylephrine intervention (this will be the secondary outcome of substudy 2)

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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