Comparative Analysis of Remimazolam and Propofol on Cerebral Oxygenation during Laminectomy (RCT effect of REMIPRO on Cerebral Oxygenation)
- Conditions
- spinal disease requiring laminectomy
- Registration Number
- jRCT1032250023
- Lead Sponsor
- None
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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.
- Uncontrolled cardiovascular diseases (e.g., heart failure, severe arrhythmias)
- Severe respiratory diseases (e.g., chronic obstructive pulmonary disease, high-risk obstructive sleep apnea syndrome [vital capacity <60%, 1-second volume <50%])
- Severe liver dysfunction (e.g., Child-Pugh classification C)
- Severe neurological diseases (evaluated by mini-cog test)
- Coagulation disorders (e.g., platelet count <80,000, PT-INR >1.5, or APTT >40 seconds)
- Uncontrolled diabetes or other metabolic disorders affecting anesthetic response
- History of allergies to remimazolam, propofol, benzodiazepines, or soy/egg-based products
- Closed-angle glaucoma
- Emergency surgery 10.Surgical procedures requiring complex operations other than laminectomy
- Spinal surgery requiring head fixation with a 3-point fixation system
- Anesthesia history within the past 30 days
- Refusal to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - mean rScO2 measured by NIRS at different time points throughout the procedure
- Secondary Outcome Measures
Name Time Method Changes in hemodynamic parameters over time MAP, HR, CO, PaO2, paCO2
Incidence of intraoperative complications hypo/hypertension, brady/tachycardia, hypoxemia
Impact of prone positioning on cerebral oxygenation and hemodynamics before versus after prone positioning changes in rScO2, MAP, PaO2, PaCO2, and CO