Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

NCT ID: NCT03185091

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-14

Study Completion Date

2017-12-01

Brief Summary

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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

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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.

Conditions

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Cerebral Arterial Aneurysm Ventricular Rate Response Pacing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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rapid ventricular pacing

Safety of rapid ventricular pacing during neurosurgical procedures

Group Type OTHER

rapid ventricular pacing

Intervention Type OTHER

Surgery

Intervention Type PROCEDURE

Interventions

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rapid ventricular pacing

Intervention Type OTHER

Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* non
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

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[email protected]

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vera Saldien, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 21937926 (View on PubMed)

Other Identifiers

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12/50/410

Identifier Type: -

Identifier Source: org_study_id

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