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Comparative Analysis of Remimazolam and Propofol on Cerebral Oxygenation during Laminectomy

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032250023
Enrollment
10
Registered
2025-04-28
Start date
2025-04-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal disease requiring laminectomy

Interventions

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

Sponsors

Lazaro Castro Betina
Lead Sponsor
Jin Zhuan
Collaborator
Ueda Kenichi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Contacts

Public ContactBetina Lazaro

Department of Anesthesiology

betina.lazaro@kameda.jp+81-4-7092-2211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026