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The Effect of Remimazolam on Somatosensory and Motor Evoked Potentials during Spinal Surgery: A Randomized Controlled Study

The Effect of Remimazolam on Somatosensory and Motor Evoked Potentials during Spinal Surgery: A Randomized Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117657
Enrollment
Unknown
Registered
2026-01-27
Start date
2025-12-08
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Spinal Surgery

Interventions

remimazolam group:Continuous intravenous pumping of remifentanil at 0.1-0.2 µg/kg/min and remimazolam at 1-2 mg/kg/h was performed intraoperatively
propofol group:Continuous intravenous pumping of remifentanil at 0.1-0.2 µg/kg/min and propofol at 5-8 mg/kg/h was performed intraoperatively

Sponsors

Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Body mass index (BMI) ranging from 18.5 to 23.9 kg/m²; 3. American Society of Anesthesiologists (ASA) physical status classification ? to ?; 4. Scheduled for spinal column and spinal cord surgery; 5. Informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. Known or suspected severe cardiac, pulmonary, hepatic or renal dysfunction (1) Severe cardiac dysfunction: a. Unstable coronary artery syndrome b. Congestive heart failure: left ventricular ejection fraction (LVEF) = 1.5 b. Serum total bilirubin (TBil) >= 171 µmol/L (4) Severe renal dysfunction: a. Endogenous creatinine clearance rate (Ccr) < 30 ml/min b. Glomerular filtration rate (GFR) < 30 ml/min•1.73 m² 2. Idiopathic epilepsy or long-term administration of antiepileptic drugs 3. Coagulopathy, other psychiatric or neurological diseases 4. History of chronic alcohol consumption or long-term use of sedative drugs 5. Hypersensitivity to remimazolam or propofol 6. Patients unable to cooperate with monitoring

Design outcomes

Primary

MeasureTime frame
Motor Evoked Potentials Amplitude;

Secondary

MeasureTime frame
Somatosensory Evoked Potentials Amplitude;Motor Evoked Potential Latency;Somatosensory Evoked Potentials Latency;Japanese Orthopaedic Association score;

Countries

China

Contacts

Public ContactRanquan Han

Beijing Tiantan Hospital Affiliated to Capital Medical University

hanrq666@aliyun.com+86 137 0128 5393

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026