The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-10

Study Completion Date

2024-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cerebral Oximetry to Reduce Organ Dysfunction After Non-cardiac Surgery

NCT03861026

Cerebral Desaturation Surgery

COMPLETED NA

Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.

NCT01760369

Regional Cerebral Oxygen Saturation During Head Rotation

COMPLETED

Cerebral Oxygenation, Different Measurement Points and Their Correlation in Pediatric Population

NCT03136952

Anesthesia Complication Surgical Blood Loss

COMPLETED

Assessment Through Transcutaneous Brain Oximetry (NIRS) of Two Preoxygenation Techniques

NCT04352049

Anesthesia; Functional

COMPLETED NA

Measuring the Effect of External Pressure on the Regional Cerebral Oxygen Saturation Monitored by Near-infrared Spectroscopy(NIRS) Technology

NCT01971996

Anaesthesia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Oxygenation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group S

27 patients will receive inhalational general anesthesia using sevoflurane.

sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843

Intervention Type DEVICE

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.

sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843

Intervention Type DEVICE

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No