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CompletedNCT00421148Updated Jan 28, 2019Results posted

Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)

A Phase 3 interventional study of Sugammadex 0.5 mg/kg and Sugammadex 1 mg/kg in Anesthesia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 28 Days to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-28.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled May 2005, registered Jan 2007).
Phase
Phase 3
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
28 Days to 65 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    Sugammadex 0.5 mg/kg

    Participants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given.

    Drug: Sugammadex 0.5 mg/kg · Drug: Rocuronium bromide

  • Experimental
    Sugammadex 1 mg/kg

    Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1 mg/kg sugammadex is to be given.

    Drug: Sugammadex 1 mg/kg · Drug: Rocuronium bromide

  • Experimental
    Sugammadex 2 mg/kg

    Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 2 mg/kg sugammadex is to be given.

    Drug: Sugammadex 2 mg/kg · Drug: Rocuronium bromide

  • Experimental
    Sugammadex 4 mg/kg

    Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 4 mg/kg sugammadex is to be given.

    Drug: Sugammadex 4 mg/kg · Drug: Rocuronium bromide

  • Placebo comparator
    Placebo

    Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single 3-mL bolus dose of placebo (sodium chloride 0.9% solution) is to be given.

    Drug: Placebo · Drug: Rocuronium bromide

Interventions

  • DrugSugammadex 0.5 mg/kg

    IV infusion

    Also known as: Org 25969, MK-8616, SCH 900616

  • DrugSugammadex 1 mg/kg

    IV infusion

    Also known as: Org 25969, MK-8616, SCH 900616

  • DrugSugammadex 2 mg/kg

    IV infusion

    Also known as: Org 25969, MK-8616, SCH 900616

  • DrugSugammadex 4 mg/kg

    IV infusion

    Also known as: Org 25969, MK-8616, SCH 900616

  • DrugPlacebo

    IV infusion

    Also known as: sodium chloride 0.9% solution

  • DrugRocuronium bromide

    IV infusion

    Also known as: ESMERON®

06

What researchers measure

Primary outcomes

  1. Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9

    Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

    Time frame: From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration)

Secondary outcomes

  1. Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7

    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.

    Time frame: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration)

  2. Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8

    Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.

    Time frame: From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration)

07

Results

Posted Jan 28, 2019

Participant flow

Recruited participants were stratified between Infants (28 days-23 months of age), Children (2-11 years of age), Adolescents (12-17 years of age) and Adults (18-65 years of age). For Participant Flow, participants are included in the treatment group to which they were randomized.

Participant flow — Overall Study
MilestoneInfants: PlaceboInfants: Sugammadex 0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgInfants: Sugammadex 4 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kg
Started22211565556666666666
Treated22211465556666666556
Completed22211465556666666456
Not completed00000100000000000210
Withdrew: Lost to follow-up00000000000000000100
Withdrew: Withdrawal by subject00000000000000000100
Withdrew: Protocol violation00000100000000000010

Outcome measures

PrimaryTime From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9

Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached ≥0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.

Time frame:
From start of sugammadex or palcebo administration to recovery of T4/T1 ratio to 0.9 (ranging from ~0.5 minutes to ~30 minutes from sugammadex or placebo administration)
Reported as:
Mean · Minutes
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9
MinutesInfants: PlaceboInfants: Sugammadex 0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kgInfants: Sugammadex 4 mg/kg
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.920.98 ± 11.303.72 ± 0.632.42 ± 0.700.58 ± NA19.57 ± 10.975.22 ± 3.503.95 ± 3.231.20 ± 0.351.57 ± 1.9022.77 ± 13.1011.97 ± 17.651.77 ± 0.371.87 ± 1.701.08 ± 0.2529.48 ± 8.433.77 ± 1.121.62 ± 0.301.27 ± 0.271.37 ± 0.380.67 ± NA
SecondaryTime From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.

Time frame:
From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.7 (ranging from ~0.4 minutes to ~20 minutes from sugammadex or placebo administration)
Reported as:
Mean · Minutes
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7
MinutesInfants: PlaceboInfants: Sugammadex 0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kgInfants: Sugammadex 4 mg/kg
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.714.85 ± 8.652.47 ± 0.071.78 ± 0.180.58 ± NA12.32 ± 7.002.62 ± 0.931.45 ± 0.380.75 ± 0.120.57 ± 0.1318.62 ± 9.722.77 ± 1.271.07 ± 0.120.95 ± 0.300.83 ± 0.2019.65 ± 5.381.62 ± 0.251.27 ± 0.350.87 ± 0.231.12 ± 0.380.42 ± NA
SecondaryTime From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8

Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (heights) of the first \& fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.

Time frame:
From start of sugammadex or placebo administration to recovery of T4/T1 ratio to 0.8 (ranging from ~0.5 minutes to ~25 minutes from sugammadex or placebo administration)
Reported as:
Mean · Minutes
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8
MinutesInfants: PlaceboInfants: Sugammadex 0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kgInfants: Sugammadex 4 mg/kg
Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.817.85 ± 10.422.97 ± 0.072.03 ± 0.170.58 ± NA14.20 ± 8.323.42 ± 1.401.85 ± 0.700.95 ± 0.230.75 ± 0.4521.92 ± 12.524.92 ± 4.081.35 ± 0.170.98 ± 0.380.87 ± 0.1824.77 ± 9.332.22 ± 0.601.37 ± 0.351.07 ± 0.231.27 ± 0.300.67 ± NA

Adverse events

Collected over Through postoperative Day 7 (Up to 8 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Infants: Placebo0/2 (0%)0/2 (0%)2/2 (100%)
Infants: Sugammadex .0.5 mg/kg0/2 (0%)1/2 (50%)1/2 (50%)
Infants: Sugammadex 1 mg/kg0/2 (0%)0/2 (0%)1/2 (50%)
Infants: Sugammadex 2 mg/kg0/1 (0%)0/1 (0%)1/1 (100%)
Infants: Sugammadex 4 mg/kg0/1 (0%)0/1 (0%)1/1 (100%)
Children: Placebo0/4 (0%)0/4 (0%)3/4 (75%)
Children: Sugammadex 0.5 mg/kg0/6 (0%)0/6 (0%)4/6 (66.7%)
Children: Sugammadex 1 mg/kg0/5 (0%)0/5 (0%)2/5 (40%)
Children: Sugammadex 2 mg/kg0/5 (0%)0/5 (0%)2/5 (40%)
Children: Sugammadex 4 mg/kg0/4 (0%)1/4 (25%)4/4 (100%)
Adolescents: Placebo0/6 (0%)0/6 (0%)5/6 (83.3%)
Adolescents: Sugammadex 0.5 mg/kg0/5 (0%)0/5 (0%)3/5 (60%)
Adolescents: Sugammadex 1 mg/kg0/6 (0%)0/6 (0%)3/6 (50%)
Adolescents: Sugammadex 2 mg/kg0/6 (0%)0/6 (0%)5/6 (83.3%)
Adolescents: Sugammadex 4 mg/kg0/8 (0%)0/8 (0%)5/8 (62.5%)
Adults: Placebo0/6 (0%)0/6 (0%)3/6 (50%)
Adults: Sugammadex 0.5 mg/kg0/6 (0%)0/6 (0%)1/6 (16.7%)
Adults: Sugammadex 1 mg/kg0/5 (0%)0/5 (0%)5/5 (100%)
Adults: Sugammadex 2 mg/kg0/5 (0%)0/5 (0%)4/5 (80%)
Adults: Sugammadex 4 mg/kg0/6 (0%)0/6 (0%)3/6 (50%)
Most frequent serious events
Most frequent serious events
EventInfants: PlaceboInfants: Sugammadex .0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgInfants: Sugammadex 4 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kg
Gastroenteritis viralInfections and infestations0/21/20/20/10/10/40/60/50/51/40/60/50/60/60/80/60/60/50/50/6
Most frequent other events
Showing 10 of 39
Most frequent other events
EventInfants: PlaceboInfants: Sugammadex .0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgInfants: Sugammadex 4 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kg
DiarrhoeaGastrointestinal disorders0/20/20/21/10/10/40/60/50/50/40/60/50/60/60/80/60/60/50/50/6
VomitingGastrointestinal disorders1/20/21/20/11/12/43/62/51/53/43/60/51/63/62/80/60/60/50/50/6
NasopharyngitisInfections and infestations0/20/20/21/10/10/40/60/50/50/40/60/50/60/60/80/60/60/50/50/6
PharyngitisInfections and infestations0/20/20/20/11/10/40/60/50/50/40/60/50/60/61/80/60/60/50/50/6
NauseaGastrointestinal disorders0/20/20/20/10/10/40/61/50/50/41/60/51/60/64/80/60/60/50/50/6
PyrexiaGeneral disorders1/20/20/20/10/10/40/60/50/50/40/60/50/60/60/80/60/60/50/51/6
RhinitisInfections and infestations1/20/20/20/10/10/40/60/50/50/40/60/50/60/60/80/60/60/50/50/6
Anaemia postoperativeInjury, poisoning and procedural complications0/20/20/20/10/10/40/60/50/52/40/60/50/60/60/80/60/60/50/50/6
Procedural complicationInjury, poisoning and procedural complications1/20/20/20/10/10/40/60/50/50/40/60/50/60/60/80/60/60/50/50/6
Procedural painInjury, poisoning and procedural complications0/20/20/20/10/11/42/61/52/51/43/61/53/63/64/81/61/62/51/51/6

Baseline characteristics

The All-Participants-Treated (APT) population consisted of all treated participants. Three additional participants withdrew from the study before receiving treatment \& were not included in the Baseline Analysis Population. For the APT population, participants with incorrect randomization are included under the actual dose group they received.

Age, Continuous
Age, Continuous(Years)Infants: PlaceboInfants: Sugammadex 0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kgInfants: Sugammadex 4 mg/kgTotal
Mean1 ± 01 ± 01 ± 00 ± NA9 ± 19 ± 38 ± 29 ± 26 ± 315 ± 214 ± 115 ± 214 ± 014 ± 249 ± 1241 ± 1737 ± 838 ± 1038 ± 141 ± NA19.8 ± 16.40
Sex: Female, Male
Sex: Female, Male(Participants)Infants: PlaceboInfants: Sugammadex 0.5 mg/kgInfants: Sugammadex 1 mg/kgInfants: Sugammadex 2 mg/kgChildren: PlaceboChildren: Sugammadex 0.5 mg/kgChildren: Sugammadex 1 mg/kgChildren: Sugammadex 2 mg/kgChildren: Sugammadex 4 mg/kgAdolescents: PlaceboAdolescents: Sugammadex 0.5 mg/kgAdolescents: Sugammadex 1 mg/kgAdolescents: Sugammadex 2 mg/kgAdolescents: Sugammadex 4 mg/kgAdults: PlaceboAdults: Sugammadex 0.5 mg/kgAdults: Sugammadex 1 mg/kgAdults: Sugammadex 2 mg/kgAdults: Sugammadex 4 mg/kgInfants: Sugammadex 4 mg/kgTotal
Female2200153323033402212038
Male0021312223533464344153
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa. PubMed 19194156 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00421148
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jan 11, 2007
Start date
May 30, 2005
Primary completion
May 31, 2006
Completion
Jun 2, 2006
Results posted
Jan 28, 2019
Last update
Jan 28, 2019

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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