The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery

NCT06325462 | Completed FDA Device

• 1 other identifier: E2232/2023
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios.

Conditions

Cerebral Oxygenation

Keywords

prone position; controlled hypotension; cerebral oximetry

Outcome Measures

Primary Outcomes (1)

• regional cerebral oxygen saturation

  By applying the sensors of regional cerebral oxygen saturation on the forehead.

  up to 24 weeks

Study Arms (2)

Group S

27 patients will receive inhalational general anesthesia using sevoflurane.

Device: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843

Group P

27 patients will receive intravenous anesthesia using propofol infusion.

Device: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843

Interventions

sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843 DEVICE

O3 regional oximetry monitors the regional hemoglobin oxygen saturation of the blood (rSO2) in adult patients, placed on the forehead by noninvasive and continuous combining arterial and venous oxygen saturation signals from near-infrared spectroscopy (NIRS)

Group P; Group S

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Fifty-four patients of both sexes between 18 and 68 years

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status I and II
• Scheduled for elective spinal surgery
• Prone position
• General anesthesia with controlled hypotension.

You may not qualify if:

• Hypertension
• Coronary artery disease
• Renal, hepatic, or cerebral insufficiency,
• Patients with coagulopathy or receiving drugs affecting coagulation
• Grossly anemic
• Hypovolemic patients
• Chronically diseased and debilitated patients,
• Bleeding more than 200 mL
• Hemodynamic instability (decrease of 25% of baseline mean arterial pressure \[MAP\] for three minutes)
• Patients with significant baseline bradycardia.

Sponsors & Collaborators

• Prince Sultan Military Medical City: lead

Study Sites (1)

Prince Sultan Military Medical City

Riyadh, 11159, Saudi Arabia

Location

Related Publications (1)

• Chaix I, Manquat E, Liu N, Casadio MC, Ludes PO, Tantot A, Lopes JP, Touchard C, Mateo J, Mebazaa A, Gayat E, Vallee F. Impact of hypotension on cerebral perfusion during general anesthesia induction: A prospective observational study in adults. Acta Anaesthesiol Scand. 2020 May;64(5):592-601. doi: 10.1111/aas.13537. Epub 2020 Jan 19.

  PMID: 31883375 RESULT

Related Links

• Effect of Deliberate Hypotension on Regional Cerebral Oxygen Saturation During Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial

Study Officials

• Mohamed A Daabiss, M.D.

  Prince Sultan Military Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 22, 2024
• Study Start: February 10, 2024
• Primary Completion: August 12, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

SA (1)