Phase 4 Double-blinded, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK- 8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

1. Is categorized as ASA Physical Status Class 1, 2, or 3 as determined
by the investigator
2. Has a planned non-emergent surgical procedure or clinical situation
(eg, intubation) that requires moderate or deep NMB with either
rocuronium or vecuronium
3. Has a surgical procedure or clinical situation that would allow
neuromuscular monitoring techniques to be applied for neuromuscular
transmission monitoring
4. Is male or female, between birth and <2 years of age at Visit 2
5. The legally acceptable representative for the study participant
provides written informed consent/assent for the trial

Exclusion Criteria

1. Is a preterm infant or neonate <36 weeks gestational age at birth
2. Has any clinically significant condition or situation (eg, anatomical
malformation that complicates intubation) other than the condition
requiring the use of NMBA that, in the opinion of the investigator, would
interfere with the trial evaluations or optimal participation in the trial
3. Has a neuromuscular disorder that may affect NMB and/or trial
assessments
4. 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)
5. Has or is suspected of having a family or personal history of malignant
hyperthermia
6. 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
7. Is expected to require mechanical ventilation after the procedure
8. 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
9. Use of medication expected to interfere with study treatments given in this
trial, as per prescribing information. Rocuronium or vecuronium are concomitant
medications to be used per label as adjunct to general anesthesia. Besides
rocuronium or vecuronium, a participant must not be
administered any other NMBA during the trial, including:
*Other steroidal NMBAs, such as pancuronium
*Nonsteroidal NMBAs such as succinylcholine or benzylisoquinolinium
compound (eg, cisatracurium). (Except in the circumstance that renewed
muscle relaxation is needed after administration of study treatment, in
which case a non-steroidal NMBA should be administered)
10. Has been previously treated with sugammadex or has participated in
a sugammadex clinical trial withi 30 days of signing the informed consent form
of this current trial
11. 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
12. Is or has an immediate family member (eg, parent/legal guardian, or
sibling) who is investigational site or Sponsor staff directly involved with
this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Part A. Pharmacokinetic parameters: Area under the plasma concentration-time<br /><br>curve (AUC), clearance (CL), apparent volume of distribution (Vz and Vss),<br /><br>maximum plasma concentration (Cmax), and half-life (t1/2)<br /><br>2. Part B. Time to neuromuscular recovery<br /><br>3. Part A and B. Number of participants experiencing adverse events.</p><br>

Secondary Outcome Measures