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

NCT ID: NCT03184233

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-14
• Study Completion Date: 2025-01-17

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cerebral aneurysm surgery with RVP

Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere (contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. During surgery subjects allocated in this study arm will undergo RVP.

Group Type: OTHER

Rapid ventricular pacing

Intervention Type: PROCEDURE

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

Craniotomy without RVP

Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere (contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored.

No rapid ventricular pacing is applied perioperatively.

Group Type: ACTIVE_COMPARATOR

No rapid ventricular pacing

Intervention Type: PROCEDURE

No rapid ventricular pacing is applied perioperatively.

Interventions

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

Intervention Type: PROCEDURE

No rapid ventricular pacing

No rapid ventricular pacing is applied perioperatively.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Davina Wildemeersch

Data manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vera Saldien, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Tomas Menovsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

Other Identifiers

17/16/205

Identifier Type: -

Identifier Source: org_study_id