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

A

Antwerp University Hospital (UZA)

Status

Enrolling

Conditions

Arteriovenous Malformations, Cerebral
Aneurysm, Brain
Cardiac Pacing, Artificial

Treatments

Procedure: No rapid ventricular pacing
Procedure: Rapid ventricular pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT03184233
17/16/205

Details and patient eligibility

About

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.

Full description

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.

Enrollment

66 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

Cerebral aneurysm surgery with RVP
Other group
Description:
Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere (contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. During surgery subjects allocated in this study arm will undergo RVP.
Treatment:
Procedure: Rapid ventricular pacing
Craniotomy without RVP
Active Comparator group
Description:
Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere (contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. No rapid ventricular pacing is applied perioperatively.
Treatment:
Procedure: No rapid ventricular pacing

Trial contacts and locations

0

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Central trial contact

Davina Wildemeersch, MD; Vera Saldien, MD

Data sourced from clinicaltrials.gov

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