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Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

Primary Purpose

Cerebral Arterial Aneurysm, Ventricular Rate Response Pacing

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
rapid ventricular pacing
Surgery
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Arterial Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • non

Sites / Locations

  • University Hospital Antwerp

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

rapid ventricular pacing

Arm Description

Safety of rapid ventricular pacing during neurosurgical procedures

Outcomes

Primary Outcome Measures

Cerebral oxygenation 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
Thermal diffusion flowmetry measures the local absolute cerebral blood flow

Secondary Outcome Measures

Electrophysiological changes in the brain during surgery
Electro-corticography measures electrophysiological changes in the brain.
Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing
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
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.

Full Information

First Posted
June 24, 2015
Last Updated
March 29, 2021
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT03185091
Brief Title
Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery
Official Title
Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2013 (Actual)
Primary Completion Date
April 11, 2016 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Arterial Aneurysm, Ventricular Rate Response Pacing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rapid ventricular pacing
Arm Type
Other
Arm Description
Safety of rapid ventricular pacing during neurosurgical procedures
Intervention Type
Other
Intervention Name(s)
rapid ventricular pacing
Intervention Type
Procedure
Intervention Name(s)
Surgery
Primary Outcome Measure Information:
Title
Cerebral oxygenation during surgery
Description
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.
Time Frame
During surgery
Title
Cerebral blood flow during surgery
Description
Thermal diffusion flowmetry measures the local absolute cerebral blood flow
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Electrophysiological changes in the brain during surgery
Description
Electro-corticography measures electrophysiological changes in the brain.
Time Frame
During surgery
Title
Effect of ventilation with 100 % oxygen on cerebral parameters after rapid ventricular pacing
Description
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.
Time Frame
Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.)
Title
Effect of hyperventilation on cerebral parameters after rapid ventricular pacing
Description
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.
Time Frame
Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: scheduled for cerebral aneurysm surgery or arterial venous malformation American Society of Anesthesiologists classification 1, 2, or 3 Exclusion Criteria: non
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21937926
Citation
Saldien V, Menovsky T, Rommens M, Van der Steen G, Van Loock K, Vermeersch G, Mott C, Bosmans J, De Ridder D, Maas AI. Rapid ventricular pacing for flow arrest during cerebrovascular surgery: revival of an old concept. Neurosurgery. 2012 Jun;70(2 Suppl Operative):270-5. doi: 10.1227/NEU.0b013e318236d84a.
Results Reference
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Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

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