Skip to main content
OpenTrials
Completed

NCT Number: NCT06325462

The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Sultan Military Medical City

Riyadh, 11159, Saudi Arabia

About this study

All patients will be monitored with standard monitoring, SedLine sedation monitor, and O3 regional oximeter, Masimo Corp, Irvine, CA. Fentanyl, propofol, and cisatracurium will be administered for anesthesia induction. Anesthetic agents will be maintained with intravenous anesthetic agents in one group and sevoflurane in another group to obtain the PSI 25-50. Mean blood pressure will be maintained 20-30% below baseline. MAP, HR, SpO2, ETCO2, and SrO2 will be assessed at supine position without oxygen administration (T1), supine position with oxygen administration (T2-baseline), intubation in the supine position (T3), just after prone positioning (T4), 10 minutes after prone positioning (T5), at the end of surgery in the prone position (T6) and at the end of anesthesia in the supine position (T7).

Data will be expressed as mean and standard deviation. The mean differences will be analyzed using the Student's T test for quantitative variables in those cases in which those variables followed a normal distribution. Distribution will be evaluated by Kolmogorov-Smirnoff's Z test. Differences in proportion will be conducted with contingency analysis using Chi-square and Fisher's exact test when needed.

A P-value < 0.05 will be statistically significant. Statistical analysis will be performed using the SPSS-PC statistical software program (version 15.0; SPSS, Inc., Chicago, IL, USA).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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)

Primary outcomes

  1. regional cerebral oxygen saturation

    Time frame: up to 24 weeks

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

Sponsors and collaborators

Lead sponsor

Prince Sultan Military Medical City

Other

Registry information

Official study title

The Influence of Different Anesthetic Techniques on Cerebral Oxygenation During Spinal Surgery in a Prone Position With Controlled Hypotension

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.