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Remimazolam Combined with Sufentanil for Elderly Frail Patients Undergoing Percutaneous Vertebroplasty: A Study on Safety and Efficacy

Remimazolam Combined with Sufentanil for Elderly Frail Patients Undergoing Percutaneous Vertebroplasty: A Study on Safety and Efficacy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121499
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Vertebral Compression Fracture

Interventions

Remimazolam (R) group:The initial dose was 2.5–5 mg. Surgery was initiated once adequate sedation was achieved (MOAA/S score <= 4). If adequate sedation was not attained after the initial dose, 1.25–2
when the MOAA/S score was <= 4, the infusion rate was adjusted to maintain continuous sedation at 0.3~0.5 mg·kg-1·h-1 . The intraoperative sedation depth was maintained at a MOAA/S score of 2–4.
Dexmedetomidine group (Group M):The initial dose was 0.3 µg/kg administered over 10 minutes. The patient’s sedation level was monitored intraoperatively
when the MOAA/S score was <= 4, the infusion rate was adjusted to maintain continuous sedation at 0.20~0.75µg·kg-1·h-1. The intraoperative sedation depth was maintained at a MOAA/S score of 2–4.

Sponsors

Huai'an Hospital Affiliated to Yangzhou University (The Fifth People's Hospital of Huai'an)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged >=65 years with a body mass index (BMI) of 18–28 kg/m^2, diagnosed as frail according to the Fried Frailty Scale, scheduled for percutaneous vertebroplasty with an operation duration not exceeding 120 minutes; those who clearly understand and voluntarily participate in this study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: Patients with hypersensitivity to benzodiazepines, opioids, or lidocaine; a history of using benzodiazepines or opioids within the past 3 months, epilepsy, any psychiatric disorder, or addiction to analgesics or hypnotics; patients scheduled for tracheal intubation; those judged to have difficult airway management; visual, auditory, or verbal communication disorders; obesity; bradycardia (heart rate (HR) < 60 beats per minute); heart block; and patients who refused to provide informed consent were excluded from the study.

Design outcomes

Primary

MeasureTime frame
Hypotension;Hypertension;Bradycardia;Tachycardia;Decreased respiratory rate;Hypoxia;Postoperative delirium;

Secondary

MeasureTime frame
Sedation duration, recovery duration;Patient and surgeon satisfaction with anesthesia management;The patient's overall pain experience;

Countries

China

Contacts

Public ContactMeijuan Sun

Huai'an Hospital Affiliated to Yangzhou University (The Fifth People's Hospital of Huai'an)

614609808@qq.com+86 152 6200 5853

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026