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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03281395
Enrollment
27
Registered
2017-09-13
Start date
2011-08-30
Completion date
2013-07-15
Last updated
2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm, Brain, Arteriovenous Malformations, Cerebral, Cardiac Pacing, Artificial

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.

Interventions

PROCEDURERapid ventricular pacing (RVP)

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

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline)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 surgeryFor detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively

Secondary

MeasureTime frameDescription
Magnetic resonance imaging or computed tomographyPreoperative and within 1 week post surgeryMagnetic resonance imaging or computed tomography 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026