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

Aneurysm, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281395
• Other study ID #: 17/16/205-2
• Status: Completed
• Phase: N/A
• First received: September 11, 2017
• Last updated: September 11, 2017
• Start date: August 30, 2011
• Est. completion date: July 15, 2013

Study information

• Verified date: September 2017
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 15, 2013
• Est. primary completion date: January 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Brain
• Arteriovenous Malformations
• Arteriovenous Malformations, Cerebral
• Cardiac Pacing, Artificial
• Congenital Abnormalities
• Hemangioma
• Intracranial Aneurysm
• Intracranial Arteriovenous Malformations

Intervention

Procedure:
• Rapid 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.
• No rapid ventricular pacing

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline)	For detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively	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	Magnetic resonance imaging or computed tomography	Magnetic 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.	Preoperative and within 1 week post surgery