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Completed

NCT Number: NCT03185091

Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery.

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Key information

Conditions

Cerebral Arterial Aneurysm Ventricular Rate Response Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

About this study

Patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery(ASA 1to 3 over 18years) receive standard care general anesthesia including central venous line for rapid ventricular pacing technique. A contralateral Foresight sensor is placed on the forehead of the patient at induction. After the craniotomy two micro electrodes(PBtO2 and cerebral blood flow) are placed in the brain and fixated. A subdural strip electrode is placed on the surface of the brain to record the electrical activity. Effect of mild hyperventilation and oxygenation with 100% O2 is evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • scheduled for cerebral aneurysm surgery or arterial venous malformation
  • American Society of Anesthesiologists classification 1, 2, or 3

Exclusion criteria

  • non

Treatment and study plan

rapid ventricular pacing

Other

Surgery

Procedure

Primary outcomes

  1. Cerebral oxygenation during surgery

    Time frame: During surgery

    Oxygenation of the brain is measured by near-infrared spectroscopy and by evaluation of the brain tissue oxygen pressure by two microelectrodes placed in the brain.

  2. Cerebral blood flow during surgery

    Time frame: During surgery

    Thermal diffusion flowmetry measures the local absolute cerebral blood flow

Secondary outcomes

  1. Electrophysiological changes in the brain during surgery

    Time frame: During surgery

    Electro-corticography measures electrophysiological changes in the brain.

  2. Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing

    Time frame: Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.)

    Effect of ventilation with 100% oxygen on cerebral blood flow and cerebral tissue oxygenation measured by thermal diffusion flowmetry and brain tissue oxygen pressure measured by microelectrodes placed in the brain in combination with near-infrared spectroscopy, respectively.

  3. Effect of hyperventilation on cerebral parameters after rapid ventricular pacing

    Time frame: Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.)

    Effect of hyperventilation (defined as arterial carbon dioxide pressure between 24 and 32 millimeter mercury) on cerebral blood flow and cerebral tissue oxygenation measured by thermal diffusion flowmetry and brain tissue oxygen pressure measured by microelectrodes placed in the brain in combination with near-infrared spectroscopy, respectively.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 14, 2017
Registry last updated
Mar 30, 2021

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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