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The efficacy and safety of mivacurium in minimally invasive endoscopic surgery

The efficacy and safety of mivacurium in minimally invasive endoscopic surgery: a prospective, randomized controlled, double-blind, single-center study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114258
Enrollment
Unknown
Registered
2025-12-09
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

None

Interventions

Rocuronium group:rocuronium is used for induction and maintenance of general anesthesia.
Mivacurium group:mivacurium is used for induction and maintenance of general anesthesia.

Sponsors

Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Understand in detail the nature, significance, possible benefits, possible inconvenience and potential risks of the trial before the trial. Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form; 2. American Society of Anaesthesiologists (ASA) classification of class I to II; 3. age >= 18 years old, gender is not limited; 4. 18kg/m^2<=BMI<=30kg/m^2; 5. Minimally invasive endoscopic procedures (support laryngoscopy, ureteroscopy and hysteroscopy) to be performed under general anaesthesia; 6. female subjects of childbearing potential who have had a negative urine pregnancy test within 7 days prior to randomisation and are not breastfeeding;

Exclusion criteria

Exclusion criteria: 1. subjects with a history of myocardial infarction or unstable angina within 6 months prior to randomisation, or a history of severe arrhythmia such as atrioventricular block of degree II or greater, or NYHA cardiac function class II or greater; 2. Subjects with a history of ischaemic stroke or transient ischaemic attack (TIA); 3. subjects with comorbid psychiatric disorders (e.g., schizophrenia, depression, etc.) and cognitive dysfunction; 4. subjects with comorbid myasthenia gravis or other neuromuscular diseases; 5. patients with known or suspected plasma cholinesterase gene purists; 6. known allergy or contraindication to mivacurium chloride or rocuronium bromide and other drugs that may be used during the trial; 7. patients with asthma; 8. severe acid-base electrolyte imbalance; 9. Screening heart rate 100 beats/min, or prolonged QTc interval on 12-lead ECG: >= 450 ms in men and >= 470 ms in women; 10. Subjects with a pre-randomisation diagnosis of refractory hypertension, or systolic blood pressure = 11.1 mmol/L; (2) Abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) >= 3×ULN and/or total bilirubin (TBiL) >= 1.5×ULN, albumin = 1.5 × ULN, or dialysis subjects; (4) Abnormal coagulation function: PT > upper limit of normal value +3s and/or APTT > upper limit of normal value +10s;

Design outcomes

Primary

MeasureTime frame
onset time;reversal rate;Time to full recovery;recovery index;

Secondary

MeasureTime frame
general adverse events;serious adverse events;

Countries

China

Contacts

Public ContactHuang huansen

Second Affiliated Hospital of Guangzhou Medical University

huanghs5480@163.com+86 20 34152524

Outcome results

None listed

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