Clinical trial NCT03184233: Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain
Official title: Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Pacing, Artificial
Aneurysm, Brain
Arteriovenous Malformations, Cerebral
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing elective cerebral aneurysm clipping surgery or arteriovenous malformation surgery will be asked to take part and give informed consent.

A control group of patients undergoing craniotomy without the use of RVP will be built in, having the same exclusion criteria. Both study groups receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Near infrared spectroscopy
timeFrame: During surgery
measure: Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample(baseline)
timeFrame: 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.
Secondary outcomes:
measure: Magnetic resonance imaging
timeFrame: Preoperative and within 1 week post surgery
measure: Occurence of arrhythmias
timeFrame: During surgery
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Vera Saldien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Tomas Menovsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: