Clinical trial NCT06325462: The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery
Official title: The Influence of Different Anesthetic Techniques on Cerebral Oxygenation During Spinal Surgery in a Prone Position With Controlled Hypotension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Oxygenation
Keywords: prone position
controlled hypotension
cerebral oximetry
Lead sponsor: Prince Sultan Military Medical City
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty-four patients of both sexes between 18 and 68 years

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).

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.

Primary outcomes:
measure: regional cerebral oxygen saturation
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Military Medical City
Study officials:
affiliation: Prince Sultan Military Medical City
name: Mohamed A Daabiss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.