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Prospective Randomized Control Trial for Comparative Analysis of Remimazolam and Propofol on Cerebral Oxygenation During Laminectomy In Prone Position Under General Anesthesia (REMIPRO RCT Cerebral oxygenation)

Comparative Analysis of Remimazolam and Propofol on Cerebral Oxygenation during Laminectomy (RCT effect of REMIPRO on Cerebral Oxygenation)

Lazaro Castro Betina

Kameda Medical Center

929 Higashicho, Kamogawa

betina.lazaro@kameda.jp

Lazaro Castro Betina

Department of Anesthesiology

929 Higashicho, Kamogawa

+81-4-7092-2211

betina.lazaro@kameda.jp

Pending

April. 28, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Eligibility Criteria for Elderly Participants (70 years or older):

Diagnosis: Presence of spinal diseases requiring single or double-level laminectomy of the thoracic and/or lumbar spine.
ASA Classification: Patients classified as ASA I-III (including relatively healthy patients and those with mild to moderate systemic diseases).
BMI: BMI between 18.5 and less than 30.
Position Tolerance: Ability to tolerate the prone position.
Informed Consent: Ability to fully understand the research plan and provide informed consent independently.
Operating Table: Spinal surgery using a surgical table such as Mizuno OSI Trios or Mizuno MOT-8300, with a pillow designed for the prone position.

1. Uncontrolled cardiovascular diseases (e.g., heart failure, severe arrhythmias)
2. Severe respiratory diseases (e.g., chronic obstructive pulmonary disease, high-risk obstructive sleep apnea syndrome [vital capacity <60%, 1-second volume <50%])
3. Severe liver dysfunction (e.g., Child-Pugh classification C)
4. Severe neurological diseases (evaluated by mini-cog test)
5. Coagulation disorders (e.g., platelet count <80,000, PT-INR >1.5, or APTT >40 seconds)
6. Uncontrolled diabetes or other metabolic disorders affecting anesthetic response
7. History of allergies to remimazolam, propofol, benzodiazepines, or soy/egg-based products
8. Closed-angle glaucoma
9. Emergency surgery
10.Surgical procedures requiring complex operations other than laminectomy
11. Spinal surgery requiring head fixation with a 3-point fixation system
12. Anesthesia history within the past 30 days
13. Refusal to participate in the study

spinal disease requiring laminectomy

Application of cerebral oximeter sensor on the forehead to monitor changes in cerebral oxygenation using remimazolam or propofol

mean rScO2 measured by NIRS at different time points throughout the procedure

Incidence of cerebral desaturation events
Incidence of postoperative delirium
Changes in hemodynamic parameters (MAP, HR, CO, PaO2, paCO2) over time
Incidence of intraoperative complications (hypo/hypertension, brady/tachycardia, hypoxemia)
Impact of prone positioning on cerebral oxygenation and hemodynamics (changes in rScO2, MAP, PaO2, PaCO2, and CO) before versus after prone positioning

+81-470922211

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