Anesthesia
Conditions
Brief 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.
Interventions
IV infusion
DRUGPlacebo
IV infusion
DRUGRocuronium bromide
IV infusion
DRUGSugammadex 0.5 mg/kg
IV infusion
IV infusion
IV infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Days to 65 Years
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 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) | 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 From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 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) | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
One adolescent participant was inadvertently randomized to Children: Sugammadex 4 mg/kg, but was included in Adolescents: Sugammadex 4 mg/kg for safety analyses. One participant was randomized to Adolescents: Sugammadex 0.5 mg/kg, but received sugammadex 5.0 mg/kg & was included in the Adolescents: Sugammadex 4 mg/kg for safety analyses.
Participants by arm
| Arm | Count |
|---|---|
| Infants: Placebo Infant participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. | 2 |
| Infants: Sugammadex 0.5 mg/kg Infant participants received an 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 was administered. | 2 |
| Infants: Sugammadex 1 mg/kg Infant participants received 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 was administered. | 2 |
| Infants: Sugammadex 2 mg/kg Infant participants received 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 was administered. | 1 |
| Children: Placebo Child participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. | 4 |
| Children: Sugammadex 0.5 mg/kg Child participants received an 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 was administered. | 6 |
| Children: Sugammadex 1 mg/kg Child participants received 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 was administered | 5 |
| Children: Sugammadex 2 mg/kg Child participants received 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 was administered. | 5 |
| Children: Sugammadex 4 mg/kg Child participants received 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 was administered. | 4 |
| Adolescents: Placebo Adolescent participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. | 6 |
| Adolescents: Sugammadex 0.5 mg/kg Adolescent participants received an 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 was administered. | 5 |
| Adolescents: Sugammadex 1 mg/kg Adolescents participants received 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 was administered. | 6 |
| Adolescents: Sugammadex 2 mg/kg Adolescent participants received 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 was administered. | 6 |
| Adolescents: Sugammadex 4 mg/kg Adolescent participants received 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 was administered. | 8 |
| Adults: Placebo Adult participants received an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of placebo (sodium chloride 0.9% solution) was administered. | 6 |
| Adults: Sugammadex 0.5 mg/kg Adult participants received an 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 was administered. | 6 |
| Adults: Sugammadex 1 mg/kg Adult participants received 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 was administered. | 5 |
| Adults: Sugammadex 2 mg/kg Adult participants received 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 was administered. | 5 |
| Adults: Sugammadex 4 mg/kg Adult participants received 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 was administered. | 6 |
| Infants: Sugammadex 4 mg/kg Infant participants received 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 was administered. | 1 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Infants: Placebo | Infants: Sugammadex 0.5 mg/kg | Infants: Sugammadex 1 mg/kg | Infants: Sugammadex 2 mg/kg | Children: Placebo | Children: Sugammadex 0.5 mg/kg | Children: Sugammadex 1 mg/kg | Children: Sugammadex 2 mg/kg | Children: Sugammadex 4 mg/kg | Adolescents: Placebo | Adolescents: Sugammadex 0.5 mg/kg | Adolescents: Sugammadex 1 mg/kg | Adolescents: Sugammadex 2 mg/kg | Adolescents: Sugammadex 4 mg/kg | Adults: Placebo | Adults: Sugammadex 0.5 mg/kg | Adults: Sugammadex 1 mg/kg | Adults: Sugammadex 2 mg/kg | Adults: Sugammadex 4 mg/kg | Infants: Sugammadex 4 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 Years STANDARD_DEVIATION 0 | 1 Years STANDARD_DEVIATION 0 | 1 Years STANDARD_DEVIATION 0 | 0 Years | 9 Years STANDARD_DEVIATION 1 | 9 Years STANDARD_DEVIATION 3 | 8 Years STANDARD_DEVIATION 2 | 9 Years STANDARD_DEVIATION 2 | 6 Years STANDARD_DEVIATION 3 | 15 Years STANDARD_DEVIATION 2 | 14 Years STANDARD_DEVIATION 1 | 15 Years STANDARD_DEVIATION 2 | 14 Years STANDARD_DEVIATION 0 | 14 Years STANDARD_DEVIATION 2 | 49 Years STANDARD_DEVIATION 12 | 41 Years STANDARD_DEVIATION 17 | 37 Years STANDARD_DEVIATION 8 | 38 Years STANDARD_DEVIATION 10 | 38 Years STANDARD_DEVIATION 14 | 1 Years | 19.8 Years STANDARD_DEVIATION 16.4 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 0 Participants | 3 Participants | 3 Participants | 4 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 6 Participants | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 1 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 4 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 4 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 2 / 2 | 1 / 2 | 1 / 2 | 1 / 1 | 1 / 1 | 3 / 4 | 4 / 6 | 2 / 5 | 2 / 5 | 4 / 4 | 5 / 6 | 3 / 5 | 3 / 6 | 5 / 6 | 5 / 8 | 3 / 6 | 1 / 6 | 5 / 5 | 4 / 5 | 3 / 6 |
| serious Total, serious adverse events | 0 / 2 | 1 / 2 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 4 | 0 / 6 | 0 / 5 | 0 / 5 | 1 / 4 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 5 | 0 / 6 |
Outcome results
Primary
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)
Population: The Per Protocol (PP) population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) \& had ≥1 post-baseline efficacy measurement for this outcome measure \& had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 20.98 Minutes | Standard Deviation 11.3 |
| Infants: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 3.72 Minutes | Standard Deviation 0.63 |
| Infants: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 2.42 Minutes | Standard Deviation 0.7 |
| Infants: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 0.58 Minutes | — |
| Children: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 19.57 Minutes | Standard Deviation 10.97 |
| Children: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 5.22 Minutes | Standard Deviation 3.5 |
| Children: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 3.95 Minutes | Standard Deviation 3.23 |
| Children: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.20 Minutes | Standard Deviation 0.35 |
| Children: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.57 Minutes | Standard Deviation 1.9 |
| Adolescents: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 22.77 Minutes | Standard Deviation 13.1 |
| Adolescents: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 11.97 Minutes | Standard Deviation 17.65 |
| Adolescents: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.77 Minutes | Standard Deviation 0.37 |
| Adolescents: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.87 Minutes | Standard Deviation 1.7 |
| Adolescents: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.08 Minutes | Standard Deviation 0.25 |
| Adults: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 29.48 Minutes | Standard Deviation 8.43 |
| Adults: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 3.77 Minutes | Standard Deviation 1.12 |
| Adults: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.62 Minutes | Standard Deviation 0.3 |
| Adults: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.27 Minutes | Standard Deviation 0.27 |
| Adults: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 1.37 Minutes | Standard Deviation 0.38 |
| Infants: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.9 | 0.67 Minutes | — |
Secondary
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)
Population: The PP population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) \& had ≥1 post-baseline efficacy measurement for this outcome measure \& had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 14.85 Minutes | Standard Deviation 8.65 |
| Infants: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 2.47 Minutes | Standard Deviation 0.07 |
| Infants: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 1.78 Minutes | Standard Deviation 0.18 |
| Infants: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 0.58 Minutes | — |
| Children: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 12.32 Minutes | Standard Deviation 7 |
| Children: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 2.62 Minutes | Standard Deviation 0.93 |
| Children: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 1.45 Minutes | Standard Deviation 0.38 |
| Children: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 0.75 Minutes | Standard Deviation 0.12 |
| Children: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 0.57 Minutes | Standard Deviation 0.13 |
| Adolescents: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 18.62 Minutes | Standard Deviation 9.72 |
| Adolescents: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 2.77 Minutes | Standard Deviation 1.27 |
| Adolescents: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 1.07 Minutes | Standard Deviation 0.12 |
| Adolescents: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 0.95 Minutes | Standard Deviation 0.3 |
| Adolescents: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 0.83 Minutes | Standard Deviation 0.2 |
| Adults: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 19.65 Minutes | Standard Deviation 5.38 |
| Adults: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 1.62 Minutes | Standard Deviation 0.25 |
| Adults: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 1.27 Minutes | Standard Deviation 0.35 |
| Adults: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 0.87 Minutes | Standard Deviation 0.23 |
| Adults: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 1.12 Minutes | Standard Deviation 0.38 |
| Infants: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.7 | 0.42 Minutes | — |
Secondary
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)
Population: The PP population consisted of all randomized participants who received a dose of study treatment (sugammadex or placebo) \& had ≥1 post-baseline efficacy measurement for this outcome measure \& had no protocol violations. For efficacy, participants with incorrect randomization were included under the planned dose group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 17.85 Minutes | Standard Deviation 10.42 |
| Infants: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 2.97 Minutes | Standard Deviation 0.07 |
| Infants: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 2.03 Minutes | Standard Deviation 0.17 |
| Infants: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 0.58 Minutes | — |
| Children: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 14.20 Minutes | Standard Deviation 8.32 |
| Children: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 3.42 Minutes | Standard Deviation 1.4 |
| Children: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 1.85 Minutes | Standard Deviation 0.7 |
| Children: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 0.95 Minutes | Standard Deviation 0.23 |
| Children: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 0.75 Minutes | Standard Deviation 0.45 |
| Adolescents: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 21.92 Minutes | Standard Deviation 12.52 |
| Adolescents: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 4.92 Minutes | Standard Deviation 4.08 |
| Adolescents: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 1.35 Minutes | Standard Deviation 0.17 |
| Adolescents: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 0.98 Minutes | Standard Deviation 0.38 |
| Adolescents: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 0.87 Minutes | Standard Deviation 0.18 |
| Adults: Placebo | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 24.77 Minutes | Standard Deviation 9.33 |
| Adults: Sugammadex 0.5 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 2.22 Minutes | Standard Deviation 0.6 |
| Adults: Sugammadex 1 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 1.37 Minutes | Standard Deviation 0.35 |
| Adults: Sugammadex 2 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 1.07 Minutes | Standard Deviation 0.23 |
| Adults: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 1.27 Minutes | Standard Deviation 0.3 |
| Infants: Sugammadex 4 mg/kg | Time From Start of Administration of Study Treatment (Sugammadex or Placebo) to Recovery T4/T1 Ratio to 0.8 | 0.67 Minutes | — |