Neuromonitoring During Rapid Ventricular Pacing in Patients Undergoing Cerebral Aneurysm Surgery

Cerebral Arterial Aneurysm Clinical Trial

Official title:

Safety of Rapid Ventricular Pacing During Cerebral Aneurysm Surgery by Multimodal Neuromonitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185091
• Other study ID #: 12/50/410
• Status: Completed
• Phase: N/A
• Start date: January 14, 2013
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 1, 2017
• Est. primary completion date: April 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled for cerebral aneurysm surgery or arterial venous malformation

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

Exclusion Criteria:

• non

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Arterial Aneurysm
• Intracranial Aneurysm
• Ventricular Rate Response Pacing

Intervention

Other:
• rapid ventricular pacing

Procedure:
• Surgery

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During surgery
Primary	Cerebral blood flow during surgery	Thermal diffusion flowmetry measures the local absolute cerebral blood flow	During surgery
Secondary	Electrophysiological changes in the brain during surgery	Electro-corticography measures electrophysiological changes in the brain.	During surgery
Secondary	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.	Intraoperative ( Start of ventilation at 100% oxygen until bloodgas analyses shows an increase in arterial oxygen pressure.)
Secondary	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.	Intraoperative (Start of hyperventilation until bloodgas analyses shows an arterial carbon dioxide pressure between 24 and 32 millimetre of mercury.)