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Efficacy and safety of original and generic sugammadex for postoperative residual neuromuscular blockade in children: a double-blind randomised controlled non-inferiority trial

Efficacy and safety of original and generic sugammadex for postoperative residual neuromuscular blockade in children: a double-blind randomised controlled non-inferiority trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086021
Enrollment
Unknown
Registered
2024-06-24
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Obstructive sleep apnea syndrome

Interventions

original sugammadex group:use of original sugammadex for postoperative residual neuromuscular blockade
generic sugammadex group :use of generic sugammadex for postoperative residual neuromuscular blockade

Sponsors

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1 Aged 2 to 17 years, 2 No gender limit, 3 ASA I ~ II, 4 OSA patients undergoing elective tonsillectomy and adenoidectomy under general anesthesia, 5 The guardian of the child signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1 under 2 years old or over 17 years old, 2 The patient had a history of allergy to the experimental drug, 3 ASA was = ?, 4 The patient was complicated with difficult airway; 5 The patient was complicated with neuromuscular disease or congenital heart disease, 6 Severe hepatic or nephritic damage, 7 Long-term use of drugs that affect neuromuscular conduction, 8 The patients and their guardians declined to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Time for the recovery of TOFR to 0.9;

Secondary

MeasureTime frame
Extubation time;PACU time;

Countries

China

Contacts

Public ContactZhang Ruidong

Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine

doctorruidong@163.com+86 189 1663 7626

Outcome results

None listed

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