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Clinical Trials/NCT06325462
NCT06325462
Completed
Not Applicable

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

Prince Sultan Military Medical City1 site in 1 country54 target enrollmentFebruary 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Oxygenation
Sponsor
Prince Sultan Military Medical City
Enrollment
54
Locations
1
Primary Endpoint
regional cerebral oxygen saturation
Status
Completed
Last Updated
11 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 10, 2024
End Date
December 1, 2024
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Prince Sultan Military Medical City
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Daabiss

Principal investigator

Prince Sultan Military Medical City

Eligibility Criteria

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.

Outcomes

Primary Outcomes

regional cerebral oxygen saturation

Time Frame: up to 24 weeks

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

Study Sites (1)

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