Clinical trial NCT03281395: Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain
Official title: Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Pacing, Artificial
Aneurysm, Brain
Arteriovenous Malformations, Cerebral
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years, schedulled for elective brain surgery and not responding to any of the exclusion criteria

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 of blood pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigator will study the safety of RVP, particularly for the heart and the brain, retrograde by studying troponin levels and magnetic resonance imaging or computed tomography.

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 of 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. In this retrograde study, the investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging or computed tomography 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 and troponin levels 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: 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 24 hours up to 60 hours after start surgery
Secondary outcomes:
measure: Magnetic resonance imaging or computed tomography
timeFrame: Preoperative and within 1 week post 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: