Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

Not Applicable

Completed

• Conditions: Ventricular Rate Response Pacing; Cerebral Arterial Aneurysm
• Interventions: Other: rapid ventricular pacing; Procedure: Surgery

• Registration Number: NCT03185091
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

To evaluate the effect of rapid ventricular pacing on the oxygenation of the brain in patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery.

Detailed Description

Patients scheduled for cerebral aneurysm clipping surgery or arteriovenous malformation surgery(ASA 1to 3 over 18years) receive standard care general anesthesia including central venous line for rapid ventricular pacing technique. A contralateral Foresight sensor is placed on the forehead of the patient at induction. After the craniotomy two micro electrodes(PBtO2 and cerebral blood flow) are placed in the brain and fixated. A subdural strip electrode is placed on the surface of the brain to record the electrical activity. Effect of mild hyperventilation and oxygenation with 100% O2 is evaluated.

Study Timeline

• Study Start: 2013-01-14
• Study First Submitted: 2015-06-24
• Primary Completion: 2016-04-11
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Completion: 2017-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• scheduled for cerebral aneurysm surgery or arterial venous malformation
• American Society of Anesthesiologists classification 1, 2, or 3

Exclusion Criteria

• non

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rapid ventricular pacing	Surgery	Safety of rapid ventricular pacing during neurosurgical procedures
rapid ventricular pacing	rapid ventricular pacing	Safety of rapid ventricular pacing during neurosurgical procedures

Primary Outcome Measures

Name	Time	Method
Cerebral oxygenation during surgery	During surgery	Oxygenation of the brain is measured by near-infrared spectroscopy and by evaluation of the brain tissue oxygen pressure by two microelectrodes placed in the brain.
Cerebral blood flow during surgery	During surgery	Thermal diffusion flowmetry measures the local absolute cerebral blood flow

Secondary Outcome Measures

Name	Time	Method
Electrophysiological changes in the brain during surgery	During surgery	Electro-corticography measures electrophysiological changes in the brain.
Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing	Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.)	Effect of ventilation with 100% oxygen on cerebral blood flow and cerebral tissue oxygenation measured by thermal diffusion flowmetry and brain tissue oxygen pressure measured by microelectrodes placed in the brain in combination with near-infrared spectroscopy, respectively.
Effect of hyperventilation on cerebral parameters after rapid ventricular pacing	Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.)	Effect of hyperventilation (defined as arterial carbon dioxide pressure between 24 and 32 millimeter mercury) on cerebral blood flow and cerebral tissue oxygenation measured by thermal diffusion flowmetry and brain tissue oxygen pressure measured by microelectrodes placed in the brain in combination with near-infrared spectroscopy, respectively.

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium