The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery

Cerebral Oxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325462
• Other study ID #: E2232/2023
• Status: Recruiting
• Start date: February 10, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Prince Sultan Military Medical City
• Contact: Mohamed A Daabiss, M.D.
• Phone: 00966508979594
• Email: mohamed.daabiss[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Oxygenation
• Hypotension

Intervention

Device:
• sensors 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)

Locations

Country	Name	City	State
Saudi Arabia	Prince Sultan Military Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sultan Military Medical City

Country where clinical trial is conducted

Saudi Arabia, 

References & 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 Anae — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	regional cerebral oxygen saturation	By applying the sensors of regional cerebral oxygen saturation on the forehead.	up to 24 weeks

External Links

•   Effect of Deliberate Hypotension on Regional Cerebral Oxygen Saturation During Functional Endoscopic Sinus Surgery: A Randomized Controlled Trial
•   Regional Cerebral Oxygen Saturation Monitoring during Spinal Surgery in Order to Identify Patients at Risk for Cerebral Desaturation