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Maximum dosage of continuous infusion of rocuronium bromide or mivacurium chloride for neuromonitoring in adolescent scoliosis surgery

Maximum dosage of continuous infusion of rocuronium bromide or mivacurium chloride for neuromonitoring in adolescent scoliosis surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082163
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-05-18
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Scoliosis

Interventions

Trial A (rocuronium bromide):The ED50 and ED95 of rocuronium bromide were determined by sequential method. The initial dosage of rocuronium bromide is 8µg·kg-1·min-1, and the adjacent dosage gradient
If MEP cannot be induced, stop the infusion of rocuronium after ruling out nerve injury and the dosage of the next patient will be reduced by 0.5µg·kg-1·min-1. Sequential infusion dose diagram of rocu
Trial B (mivacurium chloride):The ED50 and ED95 of mivacurium chloride were determined by sequential method. The initial dosage of mivacurium chloride is 10µg·kg-1·min-1, and the adjacent dosage gradi
If MEP cannot be induced, stop the infusion of mivacurium after ruling out nerve injury and the dosage of the next patient will be reduced by 0.5µg·kg-1·min-1. Sequential infusion dose diagram of miv

Sponsors

The Second Affiliated Hospital of Navy Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 12 ~ 18 years old. 2. ASA grading I~II. 3. Patients who are scheduled to undergo primary scoliosis orthopedic surgery with intraoperative neurophysiological monitoring. 4. The subject and legal guardian signed the informed consent file.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiovascular and cerebrovascular diseases. 2. Patients with severe lung diseases and asthma. 3. Patients with severe hepatic and renal dysfunction. 4. Patients with neuromuscular diseases. 5. Patients with muscle strength grade 2 and below. 6. Patients with rocuronium bromide or mivacurium chloride allergy. 7. Patients with abnormal butyrylcholinesterase levels. 8. Patients with skin breakage at the muscle relaxation monitoring site within 3 months. 9. Patients with BMI > 28 kg/m2 or BMI<18.5 kg/m2. 10. Contraindications to MEP monitoring, such as epilepsy, pacemakers and cochlear implants.

Design outcomes

Primary

MeasureTime frame
The dosage of rocuronium bromide or mivacurium chloride and the corresponding changes in MEP waveforms;

Secondary

MeasureTime frame
Mean arterial pressure;Heart rate;Intraoperative movement;Gender;Age;Height;Weight;American Association of Anesthesiologists (ASA) grade;Time of operation;Dose of vasoactive drug used;Leiden-surgical;Recovery time;Extubation time;

Countries

China

Contacts

Public ContactZhang Yixuan

The Second Affiliated Hospital of Navy Medical University

hbshczzyx@163.com+86 158 2160 7674

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026