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

Not provided0 sites60 target enrollmentStarted: TBD

Conditions

Trial Snapshot

No summary available.

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

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

Sponsor

Not provided