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Completed

NCT Number: NCT03184233

Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigators will study the safety of RVP, particularly for the heart and the brain.

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Key information

Conditions

Cardiac Pacing, Artificial Aneurysm Aneurysm, Brain Arteriovenous Malformations Arteriovenous Malformations, Cerebral Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Aneurysm Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Nervous System Diseases Nervous System Malformations Vascular Diseases Vascular Malformations

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

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. The investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging, brain oxygenation (Sct O₂) evaluated by near-infrared spectroscopy and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging, Sct O2 (3) and troponin levels (4) both markers for ischemia damage.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective cerebral aneurysm clipping surgery
  • arteriovenous malformation surgery
  • craniotomy
  • American Society of Anesthesiologists 1,2 and 3

Exclusion criteria

  • cardiac abnormalities
  • coronary heart disease
  • valvular heart disease
  • pregnancy

Treatment and study plan

Rapid ventricular pacing

Procedure

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture

No rapid ventricular pacing

Procedure

No rapid ventricular pacing is applied perioperatively.

Primary outcomes

  1. Near infrared spectroscopy

    Time frame: During surgery

    Near infrared spectroscopy measures brain oxygenation (Sct O2), a decrease of more than 10% of the initial Sct O2 or lower than 60% during pacing will be considered as a possible risk of cerebral ischaemia.

  2. Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample(baseline)

    Time frame: A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 6,12 and 24 hours after start surgery.

    For detection of myocardial injury, the cardiac specific enzyme Troponin (cTnl) is evaluated pre-and postoperatively.

Secondary outcomes

  1. Magnetic resonance imaging

    Time frame: Preoperative and within 1 week post surgery

    Magnetic Resonance Imaging of the brain pre-and postoperatively is used as standard of care. To screen for RVP induced micro-infarcts, the contralateral hemisphere (contralateral to the hemisphere operated on) and fossa posterior will be evaluated.

  2. Occurence of arrhythmias

    Time frame: During surgery

    Any disturbances of the normal rhythmic beating of the heart or myocardial contraction.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
Jun 12, 2017
Registry last updated
Jan 24, 2025

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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