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

Aneurysm, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03184233
• Other study ID #: 17/16/205
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: January 30, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Antwerp
• Contact: Vera Saldien, MD
• Phone: 38214788
• Email: vera.saldien[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• 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
• Intracranial Aneurysm
• Intracranial Arteriovenous Malformations

Intervention

Procedure:
• Rapid ventricular pacing
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
• No rapid ventricular pacing
No rapid ventricular pacing is applied perioperatively.

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	Near infrared spectroscopy	Near infrared spectroscopy measures brain oxygenation (Sct O2), a decrease of more than 10% of the initial Sct O2 or lower than 60% during pacing will be considered as a possible risk of cerebral ischaemia.	During surgery
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 6,12 and 24 hours after start surgery.
Secondary	Magnetic resonance imaging	Magnetic Resonance Imaging 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
Secondary	Occurence of arrhythmias	Any disturbances of the normal rhythmic beating of the heart or myocardial contraction.	During surgery