Anesthesia, General
Conditions
Brief summary
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).
Detailed description
In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.
Interventions
DRUGSugammadex
Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
DRUGPlacebo
0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
DRUGEsmeron®
Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants of ASA class 1 - 3, above or equal to the age of 18 years; * Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation; * Participants scheduled for surgical procedures in supine position; * Participants who had given written informed consent.
Exclusion criteria
* Participants in whom a difficult intubation because of anatomical malformations was expected; * Participants known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction; * Participants known or suspected to have a (family) history of malignant hyperthermia; * Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia; * Participants receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg\^2+; * Participants who had already participated in this trial; * Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial; * Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy; * Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (\>6 months), intrauterine device (IUD), abstinence; * Female participants who were breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | Up to 240 minutes following administration of study treatment | Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | Up to 200 minutes following administration of study treatment | Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min). |
| Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | Up to 180 minutes following administration of study treatment | Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min). |
| Number of Participants Experiencing an Adverse Event | Up to 7 days following administration of study treatment | The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. |
Participant flow
Recruitment details
Of the N=174 randomized participants, N=173 received treatment. Treated participants are counted as Started in the arm that most accurately describes the treatment received. If no treatment was received (N=1 participant), participants are counted as Started in the arm to which they were randomized.
Pre-assignment details
N=2 participants (randomized to Arm O) received (rec'd) 8 mg/kg Sugammadex, 3 minutes (min) after 1.2 mg/kg Esmeron® and are counted as Started/Treated in Arm P. Further, N=1 participant (randomized to Arm Q) rec'd 12 mg/kg Sugammadex, 29 min after 1.2 mg/kg Esmeron® and is counted as Started/Treated in Arm W.
Participants by arm
| Arm | Count |
|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® Placebo (single intravenous (IV) bolus) administered 3 minutes (min) after the bolus intubation dose of 1 mg/kg Esmeron®. | 5 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 11 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 11 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 11 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 11 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 10 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 3 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 5 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 4 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 5 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 5 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1 mg/kg Esmeron®. | 5 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® Placebo (single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 5 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® Sugammadex (2 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 10 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® Sugammadex (4 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 9 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® Sugammadex (8 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 13 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® Sugammadex (12 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 10 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® Sugammadex (16 mg/kg; single IV bolus) administered 3 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 11 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® Placebo (single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 3 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® Sugammadex (2 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 5 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® Sugammadex (4 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 5 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® Sugammadex (8 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 5 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® Sugammadex (12 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 6 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® Sugammadex (16 mg/kg; single IV bolus) administered 15 min after the bolus intubation dose of 1.2 mg/kg Esmeron®. | 5 |
| Total | 173 |
Baseline characteristics
| Characteristic | Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | Total | Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 16 | 50.4 Years STANDARD_DEVIATION 15.6 | 46.0 Years STANDARD_DEVIATION 22.4 | 51.8 Years STANDARD_DEVIATION 10.3 | 44.8 Years STANDARD_DEVIATION 19.8 | 45.0 Years STANDARD_DEVIATION 17 | 41.8 Years STANDARD_DEVIATION 21.3 | 48.0 Years STANDARD_DEVIATION 28 | 48.7 Years STANDARD_DEVIATION 15.4 | 57.5 Years STANDARD_DEVIATION 14.6 | 52.6 Years STANDARD_DEVIATION 12.6 | 47.9 Years STANDARD_DEVIATION 21.1 | 53.0 Years STANDARD_DEVIATION 16.2 | 57.2 Years STANDARD_DEVIATION 13.2 | 62.4 Years STANDARD_DEVIATION 7.9 | 56.0 Years STANDARD_DEVIATION 8.9 | 45.2 Years STANDARD_DEVIATION 17.3 | 63.0 Years STANDARD_DEVIATION 6.2 | 51.2 Years STANDARD_DEVIATION 18.9 | 43.3 Years STANDARD_DEVIATION 5.7 | 54.9 Years STANDARD_DEVIATION 17.5 | 47.5 Years STANDARD_DEVIATION 12.8 | 46.8 Years STANDARD_DEVIATION 11.3 | 48.4 Years STANDARD_DEVIATION 16.3 | 45.8 Years STANDARD_DEVIATION 17.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 171 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 11 Participants | 10 Participants | 13 Participants | 9 Participants | 10 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 10 Participants | 10 Participants | 11 Participants | 11 Participants | 11 Participants |
| Sex: Female, Male Female | 2 Participants | 80 Participants | 4 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants | 4 Participants | 3 Participants | 6 Participants | 6 Participants | 4 Participants | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 7 Participants | 5 Participants | 7 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 93 Participants | 1 Participants | 5 Participants | 4 Participants | 3 Participants | 4 Participants | 1 Participants | 5 Participants | 6 Participants | 10 Participants | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 4 Participants | 4 Participants | 8 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 | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 3 | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 10 | 0 / 9 | 0 / 13 | 0 / 10 | 0 / 11 | 0 / 3 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 5 / 5 | 5 / 11 | 7 / 11 | 7 / 11 | 8 / 11 | 6 / 10 | 2 / 3 | 4 / 5 | 3 / 4 | 4 / 5 | 3 / 5 | 4 / 5 | 3 / 5 | 5 / 10 | 7 / 9 | 5 / 13 | 6 / 10 | 9 / 11 | 3 / 3 | 2 / 5 | 3 / 5 | 1 / 5 | 3 / 6 | 3 / 5 |
| serious Total, serious adverse events | 0 / 5 | 1 / 11 | 0 / 11 | 1 / 11 | 0 / 11 | 3 / 10 | 0 / 3 | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 5 | 1 / 5 | 1 / 5 | 0 / 10 | 2 / 9 | 0 / 13 | 1 / 10 | 1 / 11 | 0 / 3 | 0 / 5 | 1 / 5 | 0 / 5 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min).
Time frame: Up to 240 minutes following administration of study treatment
Population: Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation. Additionally, N=1 participant was excluded from Arm M due to missing data and N=1 participant was excluded from Arm N due to unreliability of the neuromuscular data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 108.43 minutes | Standard Deviation 31.17 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 44.73 minutes | Standard Deviation 22.18 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 6.93 minutes | Standard Deviation 2.87 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.40 minutes | Standard Deviation 1.17 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.42 minutes | Standard Deviation 2.12 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.77 minutes | Standard Deviation 1.13 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 127.37 minutes | Standard Deviation 92.77 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 8.53 minutes | Standard Deviation 1.12 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 5.47 minutes | Standard Deviation 3.13 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.85 minutes | Standard Deviation 0.55 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.78 minutes | Standard Deviation 0.87 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 0.93 minutes | Standard Deviation 0.13 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 122.98 minutes | Standard Deviation 28.47 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 65.67 minutes | Standard Deviation 24.58 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 13.78 minutes | Standard Deviation 7.63 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 3.23 minutes | Standard Deviation 0.98 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.08 minutes | Standard Deviation 0.85 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.32 minutes | Standard Deviation 0.42 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 139.62 minutes | Standard Deviation 79.88 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 42.20 minutes | Standard Deviation 29.33 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 5.97 minutes | Standard Deviation 2.47 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 2.33 minutes | Standard Deviation 0.3 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 1.77 minutes | Standard Deviation 1.18 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9 | 4.73 minutes | Standard Deviation 6.68 |
Secondary
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.7 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.7 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min).
Time frame: Up to 180 minutes following administration of study treatment
Population: Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 91.58 minutes | Standard Deviation 27.43 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 36.43 minutes | Standard Deviation 17.22 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 4.55 minutes | Standard Deviation 1.43 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.58 minutes | Standard Deviation 0.7 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.13 minutes | Standard Deviation 0.12 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.27 minutes | Standard Deviation 0.52 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 81.70 minutes | Standard Deviation 34.18 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 5.28 minutes | Standard Deviation 0.77 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 3.28 minutes | Standard Deviation 1.62 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.25 minutes | Standard Deviation 0.15 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.28 minutes | Standard Deviation 0.42 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 0.93 minutes | Standard Deviation 0.13 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 122.90 minutes | Standard Deviation 36.23 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 54.43 minutes | Standard Deviation 17.33 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 7.45 minutes | Standard Deviation 2.82 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 2.42 minutes | Standard Deviation 0.85 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.62 minutes | Standard Deviation 0.8 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.18 minutes | Standard Deviation 0.22 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 111.37 minutes | Standard Deviation 53.03 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 24.15 minutes | Standard Deviation 13 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 3.08 minutes | Standard Deviation 0.9 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.58 minutes | Standard Deviation 0.35 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.67 minutes | Standard Deviation 0.97 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.7 | 1.22 minutes | Standard Deviation 0.57 |
Secondary
Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8
Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.8 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of NMB present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.8 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min).
Time frame: Up to 200 minutes following administration of study treatment
Population: Includes all participants receiving study treatment, having ≥1 post-baseline observation without a major protocol violation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 98.23 minutes | Standard Deviation 28.82 |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 40.00 minutes | Standard Deviation 20.47 |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 5.90 minutes | Standard Deviation 2.4 |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.87 minutes | Standard Deviation 0.73 |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.57 minutes | Standard Deviation 1.35 |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.43 minutes | Standard Deviation 0.97 |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 91.53 minutes | Standard Deviation 43.73 |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 6.23 minutes | Standard Deviation 1.23 |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 4.10 minutes | Standard Deviation 2.6 |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.45 minutes | Standard Deviation 0.43 |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.33 minutes | Standard Deviation 0.5 |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 0.93 minutes | Standard Deviation 0.13 |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 129.85 minutes | Standard Deviation 39.48 |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 60.85 minutes | Standard Deviation 21.13 |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 8.52 minutes | Standard Deviation 2.8 |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 2.80 minutes | Standard Deviation 1.02 |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.73 minutes | Standard Deviation 0.82 |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.20 minutes | Standard Deviation 0.27 |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 121.03 minutes | Standard Deviation 63.07 |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 33.95 minutes | Standard Deviation 23.02 |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 4.42 minutes | Standard Deviation 1.38 |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.98 minutes | Standard Deviation 0.27 |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.72 minutes | Standard Deviation 1.07 |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.8 | 1.27 minutes | Standard Deviation 0.6 |
Secondary
Number of Participants Experiencing an Adverse Event
The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Time frame: Up to 7 days following administration of study treatment
Population: Includes all participants receiving study treatment. N=2 participants (originally randomized to Arm O), rec'd 8 mg/kg sugammadex, 3 min after 1.2 mg/kg Esmeron® (counted in Arm P). N=1 participant (originally randomized to Arm Q) rec'd 12 mg/kg sugammadex, 29min after 1.2 mg/kg Esmeron® (counted in Arm W).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A. Placebo; 3 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 5 Participants |
| Arm B. 2 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 5 Participants |
| Arm C. 4 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 7 Participants |
| Arm D. 8 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 7 Participants |
| Arm E. 12 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 8 Participants |
| Arm F. 16 mg/kg Sugammadex; 3 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 7 Participants |
| Arm G. Placebo; 15 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 2 Participants |
| Arm H. 2 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm I. 4 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |
| Arm J. 8 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm K. 12 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |
| Arm L. 16 mg/kg Sugammadex; 15 Min After 1 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm M. Placebo; 3 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |
| Arm N. 2 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 5 Participants |
| Arm O. 4 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 7 Participants |
| Arm P. 8 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 5 Participants |
| Arm Q. 12 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 6 Participants |
| Arm R. 16 mg/kg Sugammadex; 3 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 9 Participants |
| Arm S. Placebo; 15 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |
| Arm T. 2 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 2 Participants |
| Arm U. 4 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 4 Participants |
| Arm V. 8 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 1 Participants |
| Arm W. 12 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |
| Arm X. 16 mg/kg Sugammadex; 15 Min After 1.2 mg/kg Esmeron® | Number of Participants Experiencing an Adverse Event | 3 Participants |