Phase 3
Completed N=94
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
Anesthesia
Source: ClinicalTrials.gov NCT00421148 ↗
Enrolled (actual)
94
Serious AEs
2.2%
Results posted
Jan 2019
Primary outcomePrimary: Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 — 20.98; 3.72; 2.42; 0.58 Minutes
◆ Published Evidence
Highly cited
▲ Trending
204citations · ~12 / year
Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients.
Summary
The purpose of this study is:
* to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants
* to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants, and to evaluate the safety of sugammadex in pediatric and adult participants.
Linked Publications
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Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 |
20.98; 3.72; 2.42; 0.58; 19.57; 5.22 | — |
| SECONDARY Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 |
14.85; 2.47; 1.78; 0.58; 12.32; 2.62 | — |
| SECONDARY Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 |
17.85; 2.97; 2.03; 0.58; 14.20; 3.42 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) class 1 - 2, between the ages of 28 days and 65 years inclusive, and between the ages of 2 and 65 years inclusive for Germany and between the ages of 6 and 65 years inclusive for Finland
- Scheduled for general anesthesia with an anticipated duration of anesthesia of at least 60 minutes, without further need for muscle relaxation other than one single dose of 0.6 mg/kg rocuronium
- Scheduled for surgical procedures in the supine position
- Participants who, and/or whose parent(s) or legal guardian(s) have given written informed consent [or appropriate assent, if applicable]
Exclusion Criteria
- Known or suspected neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction, in Germany creatinine and blood urea nitrogen outside local reference ranges
- Known or suspected to have a (family) history of malignant hyperthermia
- Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- Use of medication expected to interfere with the rocuronium given in this trial, based on the dose and the time of administration
- Pregnancy
- Childbearing potential not using any of the following methods of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence
- Breast-feeding
- Prior participation in any study with Org 25969 (sugammadex)
- Participation in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into study 19.4.306 (MK-8616-034, P05961)
Data sourced from ClinicalTrials.gov (NCT00421148) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.