Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325462
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-09
Brief Title:
The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery
Sponsor:
Prince Sultan Military Medical City
Organization:
Prince Sultan Military Medical City
Study Overview
Official Title:
The Influence of Different Anesthetic Techniques on Cerebral Oxygenation During Spinal Surgery in a Prone Position With Controlled Hypotension
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Students T test for quantitative variables in those cases in which those variables followed a normal distribution Distribution will be evaluated by Kolmogorov-Smirnoffs Z test Differences in proportion will be conducted with contingency analysis using Chi-square and Fishers exact test when needed
A P-value 005 will be statistically significant Statistical analysis will be performed using the SPSS-PC statistical software program version 150 SPSS Inc Chicago IL USA
Data will be expressed as mean and standard deviation The mean differences will be analyzed using the Students T test for quantitative variables in those cases in which those variables followed a normal distribution Distribution will be evaluated by Kolmogorov-Smirnoffs Z test Differences in proportion will be conducted with contingency analysis using Chi-square and Fishers exact test when needed
A P-value 005 will be statistically significant Statistical analysis will be performed using the SPSS-PC statistical software program version 150 SPSS Inc Chicago IL USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None