Anesthesia, General
Conditions
Brief summary
The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.
Interventions
DRUGSugammadex
Sugammadex solution for injection.
DRUGRocuronium
Rocuronium bromide solution for injection.
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
* American Society of Anesthesiologists (ASA) Class 1 to 3; * Has been diagnosed with or having a past history of pulmonary disease; * Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium; * Is scheduled for surgery in supine position; * Has given written informed consent;
Exclusion criteria
* Is expected to have a difficult intubation due to anatomical malformations; * Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction; * Has known or suspected of having a (family) history of malignant hyperthermia; * Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery; * Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+; * Is a female who is pregnant or breast-feeding; * Is a female of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\] or using only hormonal contraception as birth control; * Has already participated in a sugammadex trial including Protocol 19.4.308; * Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease | Up to 90 minutes | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. |
| Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE) | Up to 7 days | The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE) | Up to 7 days | The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | Up to 6 hours (prior to discharge from the recovery room) | The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation. |
| Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Up to 6 hours (prior to transfer to the recovery room after extubation) | The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task. |
| Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease | Up to 90 minutes | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. |
| General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Up to 6 hours (prior to transfer to the recovery room after extubation) | Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician. |
| General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room | Up to 6 hours (prior to discharge from the recovery room) | Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician. |
| Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room | Up to 6 hours (prior to discharge from the recovery room) | The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task. |
| Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease | Up to 90 minutes | The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX. |
| Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Up to 6 hours (prior to transfer to the recovery room after extubation) | The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation. |
Participant flow
Recruitment details
Participants were enrolled at 9 study sites in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg After the intravenous (IV) intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 2.0 mg/kg. | 39 |
| Rocuronium + Sugammadex 4.0 mg/kg After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants received IV sugammadex 4.0 mg/kg. | 38 |
| Total | 77 |
Baseline characteristics
| Characteristic | Rocuronium + Sugammadex 2.0 mg/kg | Rocuronium + Sugammadex 4.0 mg/kg | Total |
|---|---|---|---|
| Age, Continuous | 49 Years STANDARD_DEVIATION 17 | 46 Years STANDARD_DEVIATION 14 | 47 Years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 30 Participants | 27 Participants | 57 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 38 |
| other Total, other adverse events | 38 / 39 | 34 / 38 |
| serious Total, serious adverse events | 4 / 39 | 3 / 38 |
Outcome results
Primary
Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Up to 7 days
Population: All randomized participants who received sugammadex are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE) | 0 Percentage of Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE) | 0 Percentage of Participants |
Primary
Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)
The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Up to 7 days
Population: All randomized participants who received sugammadex are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE) | 97.4 Percentage of Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE) | 94.7 Percentage of Participants |
Primary
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Time frame: Up to 90 minutes
Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 11 participants (2.0 mg/kg n=6 and 4.0 mg/kg n=5), data were missing due to watch malfunction (n=2), the data that was obtained was considered unreliable (n=6), or the watch was removed prior to recovery to 0.9 (n=3).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease | 2.42 Minutes | Standard Deviation 1.93 |
| Rocuronium + Sugammadex 4.0 mg/kg | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease | 2.1 Minutes | Standard Deviation 1.8 |
Secondary
Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.
Time frame: Up to 6 hours (prior to transfer to the recovery room after extubation)
Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Able to perform | 23 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Not able to perform | 5 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Able to perform | 29 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Not able to perform | 5 Participants |
Secondary
Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room
The ability of each cooperative (based on clinician determination) participant to perform a 5-second head lift was determined by the clinician. Participants were rated as either able or not able to complete the head lift task.
Time frame: Up to 6 hours (prior to discharge from the recovery room)
Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room | Able to perform | 39 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room | Not able to perform | 0 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room | Able to perform | 37 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room | Not able to perform | 1 Participants |
Secondary
General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.
Time frame: Up to 6 hours (prior to transfer to the recovery room after extubation)
Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Muscle Weakness | 3 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | No Muscle Weakness | 25 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Muscle Weakness | 4 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | No Muscle Weakness | 30 Participants |
Secondary
General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room
Each cooperative (based on clinician determination) participant was assessed by a clinician to determine if there was muscle weakness. Participants were rated as having or not having muscle weakness by the clinician.
Time frame: Up to 6 hours (prior to discharge from the recovery room)
Population: All randomized and cooperative participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room | Muscle Weakness | 4 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room | No Muscle Weakness | 35 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room | Muscle Weakness | 6 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room | No Muscle Weakness | 32 Participants |
Secondary
Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
The level of consciousness prior to transfer to the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.
Time frame: Up to 6 hours (prior to transfer to the recovery room after extubation)
Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure. One participant in the 4.0 mg/kg group had missing data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Awake and oriented | 17 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Arousable with minimal stimulation | 16 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Responsive only to tactile stimulation | 6 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Missing data | 0 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Missing data | 1 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Awake and oriented | 22 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Responsive only to tactile stimulation | 2 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation | Arousable with minimal stimulation | 13 Participants |
Secondary
Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room
The level of consciousness prior to discharge from the recovery room was determined by the clinician for each participant. Each participants was assigned 1 of 3 potential levels of consciousness: 1) awake and oriented; 2) arousable with minimal stimulation; or 3) responsive only to tactile stimulation.
Time frame: Up to 6 hours (prior to discharge from the recovery room)
Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment for the outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | Awake and oriented | 38 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | Arousable with minimal stimulation | 1 Participants |
| Rocuronium + Sugammadex 2.0 mg/kg | Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | Responsive only to tactile stimulation | 0 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | Awake and oriented | 38 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | Arousable with minimal stimulation | 0 Participants |
| Rocuronium + Sugammadex 4.0 mg/kg | Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room | Responsive only to tactile stimulation | 0 Participants |
Secondary
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.7 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Time frame: Up to 90 minutes
Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 6 participants (2.0 mg/kg n=3 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=4).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease | 1.5 Minutes | Standard Deviation 0.55 |
| Rocuronium + Sugammadex 4.0 mg/kg | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease | 1.35 Minutes | Standard Deviation 0.45 |
Secondary
Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease
The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.8 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.
Time frame: Up to 90 minutes
Population: All randomized participants who received sugammadex and had ≥1 post-baseline assessment of the outcome measure. For 7 participants (2.0 mg/kg n=4 and 4.0 mg/kg n=3), data were unavailable due to TOF-Watch® malfunction (n=2), or the data that was obtained was considered unreliable (n=5).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium + Sugammadex 2.0 mg/kg | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease | 1.8 Minutes | Standard Deviation 0.82 |
| Rocuronium + Sugammadex 4.0 mg/kg | Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease | 1.62 Minutes | Standard Deviation 0.65 |