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Effect of remimazolam vs propofol on consciousness recovery in elderly patients undergoing neuroelectrophysiological monitoring of spinal surgery:a single-center, double-blind, randomized controlled study

Effect of remimazolam vs propofol on consciousness recovery in elderly patients undergoing neuroelectrophysiological monitoring of spinal surgery:a single-center, double-blind, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099677
Enrollment
Unknown
Registered
2025-03-27
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Recovery of consciousness in elderly patients undergoing spinal surgery

Interventions

Intervention group:Remimazolam 0.025-0.1mg/kg was induced, 0.1-0.7 mg/kg/h was maintained , and 0.5mg (5ml) of flumaxinil was antagonized after drug withdrawal
Control group:Propofol 1-1.5mg/kg was induced, 4-10mg/kg/h was maintained, and the same amount of normal saline was given after drug withdrawal.

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=60 years; 2. Patients who intend to undergo spinal surgery under general anesthesia, including lumbar fusion surgery, cervical spine surgery, etc.; 3. ASA Class I-III; 4. Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery; 2. Inability to communicate verbally; 3. Preoperative insanity or dementia; 4. Other conditions, including intolerance or hypersensitivity to propofol or benzodiazepines, myasthenia gravis, schizophrenia, and severe depressive states; 5. Severe cardiac and pulmonary insufficiency.

Design outcomes

Primary

MeasureTime frame
The recovery time of consciousness in remazolam group and propofol group,;

Secondary

MeasureTime frame
Time of loss of consciousness after induction;Changes of MEP and SSEP amplitude in two groups of patients;Hypotension after anesthesia induction;Incidence of agitation during recovery;Incidence of re-sedation after awakening;Rate of PONV;Within 3 days after surgery;;Quality of recovery within 3 days after surgery;

Countries

China

Contacts

Public ContactWeifeng Yao

The Third Affiliated Hospital of Sun Yat-sen University

yaowf3@mail.sysu.edu.cn+86 189 2210 0076

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026