Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

• Sponsor: University Hospital, Antwerp (Other)
• Overall Status: Completed
• CT.gov ID: NCT03185091
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Arm: 1
• Actual Duration (Months): 58.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Arterial Aneurysm; Ventricular Rate Response Pacing	Other: rapid ventricular pacing; Procedure: Surgery	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring
• Actual Study Start Date: Jan 14, 2013
• Actual Primary Completion Date: Apr 11, 2016
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: rapid ventricular pacing Safety of rapid ventricular pacing during neurosurgical procedures	Other: rapid ventricular pacing; Procedure: Surgery

Outcome Measures

Primary Outcome Measures

1. 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.

2. Cerebral blood flow during surgery [During surgery]

   Thermal diffusion flowmetry measures the local absolute cerebral blood flow

Secondary Outcome Measures

1. Electrophysiological changes in the brain during surgery [During surgery]

   Electro-corticography measures electrophysiological changes in the brain.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• scheduled for cerebral aneurysm surgery or arterial venous malformation

• American Society of Anesthesiologists classification 1, 2, or 3

Exclusion Criteria:

• non

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Antwerp	Edegem	Antwerp	Belgium	2650

Sponsors and Collaborators

• University Hospital, Antwerp

Investigators

• Principal Investigator: Vera Saldien, MD, University Hospital, Antwerp

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.

• Responsible Party: [e-mail], Principal Investigator, University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT03185091
• Other Study ID Numbers: 12/50/410
• First Posted: Jun 14, 2017
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Intracranial Aneurysm; Aneurysm

Study Results

No Results Posted as of Mar 30, 2021