Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)

Completed · Phase 4

Conditions studied: Neuromuscular Blockade

In brief

This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to \<2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.

Key facts

Study ID: NCT03909165
Run by: Merck Sharp & Dohme LLC
People needed: 145
Starts: 2019-07-23
Expected to finish: 2023-09-21
Last updated by the study team: 2025-07-25

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1, 2, or 3.
Has a planned non-emergent surgical procedure or clinical situation (e.g., intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.
Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring.
Is male or female, between birth and <2 years of age.

You may not qualify if…

Is a preterm infant or neonate <36 weeks gestational age at birth.
Has any clinically significant condition or situation (e.g., 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.
Has a neuromuscular disorder that may affect NMB and/or trial assessments.
Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency.
Has or is suspected of having a family or personal history of malignant hyperthermia.
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.
Is expected to require mechanical ventilation after the procedure.
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.
Use of medication expected to interfere with study treatments given in this trial.
Has been previously treated with sugammadex or has participated in a sugammadex clinical trial within 30 days of signing the informed consent form of this current trial.
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.

Where it is running

Lucille Packard Children's Hospital ( Site 3008) — Palo Alto, California, United States
Variety Children's Hospital D.B.A. Nicklaus Children's Hospital ( Site 3019) — Miami, Florida, United States
OU Medical Center ( Site 3005) — Oklahoma City, Oklahoma, United States
The Children's Hospital of Philadelphia ( Site 3021) — Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh UPMC ( Site 3017) — Pittsburgh, Pennsylvania, United States
McGovern Medical School at UT Health/ Memorial Hermann ( Site 3014) — Houston, Texas, United States
University of Vermont Medical Center ( Site 3013) — Burlington, Vermont, United States
The Children s Hospital at Westmead ( Site 3805) — Westmead, New South Wales, Australia
Queensland Children s Hospital ( Site 3806) — South Brisbane, Queensland, Australia
Royal Childrens Hospital Melbourne ( Site 3801) — Parkville, Victoria, Australia
Universitaire Ziekenhuis Antwerpen - UZA ( Site 3200) — Edegem, Antwerpen, Belgium
UZ Brussel ( Site 3201) — Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven - Campus Gasthuisberg ( Site 3202) — Leuven, Vlaams-Brabant, Belgium
Hospital Pequeno Principe ( Site 3826) — Curitiba, Paraná, Brazil
Hospital Tacchini ( Site 3827) — Bento Gonçalves, Rio Grande do Sul, Brazil
Instituto da Crianca do Hospital das Clinicas-FMUSP ( Site 3825) — São Paulo, Brazil
Rigshospitalet ( Site 3250) — Copenhagen, Capital Region, Denmark
New Childrens Hospital ( Site 3750) — Helsinki, Uusimaa, Finland
C.H.R.U. de Lille. Hopital Jeanne de Flandres ( Site 3304) — Lille, Nord, France
Unidad de Cirugía Cardiovascular ( Site 4126) — Guatemala City, Guatemala
Szegedi Tudomanyegyetem ( Site 4201) — Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 4200) — Debrecen, Hungary
Sarawak General Hospital ( Site 3877) — Kuching, Sarawak, Malaysia
Women and Children Hospital Kuala Lumpur (Hospital Tunku Azizah) ( Site 3875) — Kuala Lumpur, Malaysia
University Malaya Medical Centre. ( Site 3876) — Kuala Lumpur, Malaysia

Full record on ClinicalTrials.gov

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