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A prospective randomized controlled trial of remimazolam versus propofol on cerebral oxygenation during laminectomy in prone position under general anesthesia (PRO-REM Trial)

A prospective randomized controlled trial of remimazolam versus propofol on cerebral oxygenation during laminectomy in prone position under general anesthesia (PRO-REM Trial)

Ueda Kenichi

Kameda Medical Center

929, Higashi-cho, Kamogawa City, Chiba

ueda.kenichi@kameda.jp

Lazaro Betina

Kameda Medical Center

929, Higashi-cho, Kamogawa City, Chiba

+81-4-7092-2211

betina.lazaro@kameda.jp

Recruiting

Mar. 06, 2026

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

treatment purpose

1. Elderly patients over 65 years of age
2. Diagnosis: Patients with spinal disease at the thoracic and/or lumbar level requiring laminectomy, discectomy, and/or posterior spinal fusion
3. ASA classification: Patients classified as ASA I-III (including relatively healthy patients to patients with mild to moderate systemic disease)
4. BMI greater than or equal to 18 or less than or equal to 35
5. Able to tolerate prone position
6. Able to fully understand the study plan and provide informed consent on their own
7. Operating table: Spine surgery using a prone pillow, such as the Mizuno OSI Trios operating table or the Mizuno MOT-8300

1. Uncontrolled cardiovascular disease (e.g., EF<30% heart failure, Af, other severe arrhythmias)
2. Severe respiratory disease (e.g., chronic obstructive pulmonary disease, high-risk obstructive sleep apnea (vital capacity <60%, volume <50%))
3. Severe hepatic impairment (e.g., Child-Pugh classification C)
4. Severe neurological disease (assessed by mini-cog test)
5. History of allergy to remimazolam, propofol, benzodiazepines, or soy/egg-based products
6. Angle-closure glaucoma
7. Emergency surgery
8. Spine surgery requiring head fixation with 3-point fixation
9. Refusal to participate in the study

Both

Patients with spinal disease at the thoracic and/or lumbar level requiring laminectomy, discectomy,

Patients undergoing spine surgery in the prone position will be randomized to remimazolam (Group R) or propofol (Group P), with continuous cerebral oximetry monitoring and hemodynamics-guided vasopressor administration.

spinal stenosis

Laminectomy

D013130

D007796

Between-group difference in time-weighted average delta rScO2 in the prone position relative to pre-induction supine baseline.

1. Incidence of cerebral oxygen saturation decrease events
2. Incidence of postoperative delirium and cognitive function decline
3. Temporal changes in hemodynamic parameters (MAP, heart rate, CO, CI)
4. Incidence of intraoperative complications (hypotension/hypertension, bradycardia/tachycardia, hypoxemia), and frequency and amount of vasopressor use
5. Effect of the prone position on cerebral oxygen saturation and hemodynamics (changes in rScO2, MAP, CI, and CO before and after prone positioning)
6. Time from end of surgery to extubation and confirmation of neurological findings

+81-4-7092-2211

Feb. 05, 2026

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