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The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06325462
Enrollment
54
Registered
2024-03-22
Start date
2024-02-10
Completion date
2024-12-01
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Oxygenation

Keywords

prone position, controlled hypotension, cerebral oximetry

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.

Detailed description

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).

Interventions

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

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)

Sponsors

Prince Sultan Military Medical City
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 68 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
regional cerebral oxygen saturationup to 24 weeksBy applying the sensors of regional cerebral oxygen saturation on the forehead.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026