The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery

May 13, 2025 updated by: Mohamed Daabiss, Prince Sultan Military Medical City

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11159
        • Prince Sultan Military Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Fifty-four patients of both sexes between 18 and 68 years

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group S
27 patients will receive inhalational general anesthesia using sevoflurane.
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)
Group P
27 patients will receive intravenous anesthesia using propofol infusion.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
regional cerebral oxygen saturation
Time Frame: up to 24 weeks
By applying the sensors of regional cerebral oxygen saturation on the forehead.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince Sultan Military Medical City

Investigators

  • Principal Investigator: Mohamed A Daabiss, M.D., Prince Sultan Military Medical City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2024

Primary Completion (Actual)

August 12, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2232/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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