PK, safety and efficacy of sugammadex in children 2 to <17 years of age

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 288

Inclusion Criteria

1. Must be categorized as ASA Physical Status Class 1, 2, or 3, as determined by the investigator
2. Have a planned non-emergent surgical procedure or clinical situation (eg, intubation) that requires moderate or deep NMB with either rocuronium or vecuronium
3. Have a planned surgical procedure or clinical situation that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring
4. Age between 2 to <17 years at Visit 2.
5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
a.) Not a woman of childbearing potential (WOCBP)
OR
b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment
6. The participant (and/or legally acceptable representative, if applicable) provides written informed consent/assent for the trial
Are the trial subjects under 18? yes
Number of subjects for this age range: 238
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial
2. Has a neuromuscular disorder that may affect NMB and/or trial assessments
3. Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate (eGFR) <30 ml/min; using revised Schwartz estimate as method of calculation)
4. Has or is suspected of having a family or personal history of malignant hyperthermia
5. Has or is suspected of having an allergy to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia
6. Has received or is planned to receive toremifene and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment
7. A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
8. Use of medication expected to interfere with study treatments given in this trial, as per prescribing information
9. Has been previously treated with sugammadex or has participated in a sugammadex clinical trial
10. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial
11. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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