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Population pharmacokinetic/pharmacodynamic study of sugammadex for reversing rocuronium neuromuscular block after surgery in children under 3 years old

Population pharmacokinetic/pharmacodynamic study of sugammadex for reversing rocuronium neuromuscular block after surgery in children under 3 years old

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022542
Enrollment
Unknown
Registered
2019-04-16
Start date
2019-04-15
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Neuromuscular block for surgical anesthesia in children

Interventions

M Group:Rocuronium and sugammadex for moderate neuromuscular block in laparoscopic surgery in children under 3 years old
D Group:Rocuronium and sugammadex for deep neuromuscular block in laparoscopic surgery in children under 3 years old

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.3 Years to 3 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing endotracheal intubation or laryngeal mask ventilation during day surgery; 2. Children between the ages of 3 months and 3 years old; 3. intraoperative use of a single dose of rocuronium, postoperative use of sugammadex to reverse the neuromuscular block of rocuronium; 4. ASA grade I-II.

Exclusion criteria

Exclusion criteria: (1) known or potential neuromuscular disorders; (2) using a drug that interacts with rocuronium or a drug that affects nerve-muscle conduction; (3) malnutrition or excessive obesity before surgery; (4) obvious heart, lung disease or abnormal liver and kidney function; (5) Patients with a family history of allergies or malignant hyperthermia for general anesthesia; (6) Patients with obvious cardiopulmonary, hematological, endocrine or metabolic gastrointestinal diseases.

Design outcomes

Primary

MeasureTime frame
Muscle relaxant effect;TOFr recovery time;Rocuronium plasma concentration;sugammadex plasma concentration;Vital signs;

Secondary

MeasureTime frame
Postoperative pain;surgical condition;Postoperative adverse events;

Contacts

Public ContactLibilian

Guangzhou Women and Children Medical Center

32417024@qq.com+86 13570226780

Outcome results

None listed

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