Neuromuscular Blockade
Conditions
Brief summary
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.
Detailed description
The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.
Interventions
DRUGsugammadex
At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered.
DRUGRocuronium
After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * American Society of Anesthesiologists (ASA) Class \>=4 * Creatinine clearance (CLCR) \< 30 mL/min and clinical indication for dialysis * Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium * Scheduled for a (surgical) procedure in supine position * Written informed consent (of the legal representative)
Exclusion criteria
* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction * 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 * Have already participated in a sugammadex trial * Have participated in another clinical trial, not preapproved by NV Organon, within 30 days of study entry * Females who are pregnant\* * Females who are breast-feeding \* In females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) | Up to day 7 | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR. |
| Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) | Up to Day 7 | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR. |
| Rate of Clearance of Sugammadex From Blood | Up to day 7 | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points. |
| Rate of Clearance of Rocuronium From Blood | Up to Day 7 | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points. |
| Rate of Clearance of Sugammadex From Dialysate | Up to day 7 | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable. |
| Rate of Clearance of Rocuronium From Dialysate | Up to Day 7 | Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Physical Examinations | Screening up to day 7 | Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery |
| Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1 | Day 1 | Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from \>= 0.9 to \< 0.8 in at least three consecutive measurements. |
| Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium | Day 1 | Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium |
| Number of Participants With Pre-treatment Adverse Events (AEs) | Screening up to Day 1 | An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product. |
| Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9 | Day 1 | Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. |
| Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8 | Day 1 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. |
| Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7 | Day 1 | Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. |
| Number of Participants With Pregnancies at 30 Days Post-dose | Up to 30 days post -dose | Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants |
| Number of Participants With Serious Adverse Events (SAEs) | Up to day 7 | A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect |
| Number of Participants With Medical Device (Near) Incidents | Up to day 7 | A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health. |
| Vital Sign: Mean Systolic Blood Pressure | Screening up to 1 day after surgery | Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery |
| Vital Sign: Mean Diastolic Blood Pressure | Screening up to 1 day after surgery | Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery |
| Vital Sign: Mean Heart Rate | Screening up to 1 day after surgery | Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugammadex IV single bolus dose of 4.0 mg/kg sugammadex | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | Sugammadex |
|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 2 / 6 |
Outcome results
Primary
Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR)
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of rocuronium determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of rocuronium at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.
Time frame: Up to Day 7
Population: All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) | First Dialysis (n=5) | 0.750 Reduction Ratio | Standard Deviation 0.0786 |
| Sugammadex | Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) | Second Dialysis (n=6) | 0.625 Reduction Ratio | Standard Deviation 0.144 |
| Sugammadex | Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) | Third Dialysis (n=4) | 0.521 Reduction Ratio | Standard Deviation 0.0489 |
| Sugammadex | Clearance of Rocuronium by Dialysis as Measured by the Reduction Ratio (RR) | Fourth Dialysis (n=4) | 0.458 Reduction Ratio | Standard Deviation 0.115 |
Primary
Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR)
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected before, and after hemodialysis, with concentrations of sugammadex determined using a liquid chromatographic assay with mass spectrometric detection. The clearance of sugammadex at each dialysis session was calculated by measuring the ratio of plasma concentration at the end of dialysis, average duration of 6 hours, compared with that immediately before the start of dialysis, called the RR.
Time frame: Up to day 7
Population: All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) | First Dialysis (n=5) | 0.687 Reduction Ratio | Standard Deviation 0.113 |
| Sugammadex | Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) | Second Dialysis (n=6) | 0.566 Reduction Ratio | Standard Deviation 0.15 |
| Sugammadex | Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) | Third Dialysis (n=4) | 0.516 Reduction Ratio | Standard Deviation 0.232 |
| Sugammadex | Clearance of Sugammadex by Dialysis as Measured by the Reduction Ratio (RR) | Fourth Dialysis (n=4) | 0.532 Reduction Ratio | Standard Deviation 0.144 |
Primary
Rate of Clearance of Rocuronium From Blood
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.
Time frame: Up to Day 7
Population: All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Rate of Clearance of Rocuronium From Blood | First Dialysis (n=5) | 80.2 mL/min | Standard Deviation 15.2 |
| Sugammadex | Rate of Clearance of Rocuronium From Blood | Second Dialysis (n=6) | 86.3 mL/min | Standard Deviation 14.1 |
| Sugammadex | Rate of Clearance of Rocuronium From Blood | Third Dialysis (n=4) | 94.1 mL/min | Standard Deviation 14.8 |
| Sugammadex | Rate of Clearance of Rocuronium From Blood | Fourth Dialysis (n=3) | 94.8 mL/min | Standard Deviation 9.68 |
Primary
Rate of Clearance of Rocuronium From Dialysate
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of rocuronium were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.
Time frame: Up to Day 7
Population: All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Rate of Clearance of Rocuronium From Dialysate | First Dialysis (n=5) | 75.1 mL/min | Standard Deviation 5.81 |
| Sugammadex | Rate of Clearance of Rocuronium From Dialysate | Second Dialysis (n=6) | 97.2 mL/min | Standard Deviation 32.4 |
| Sugammadex | Rate of Clearance of Rocuronium From Dialysate | Third Dialysis (n=4) | 110 mL/min | Standard Deviation 36.4 |
| Sugammadex | Rate of Clearance of Rocuronium From Dialysate | Fourth Dialysis (n=4) | 95.3 mL/min | Standard Deviation 19.2 |
Primary
Rate of Clearance of Sugammadex From Blood
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Blood samples were collected from ports in the arterial and venous tubing of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from blood at each dialysis session was assessed by averaging across all available collection time points.
Time frame: Up to day 7
Population: All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Rate of Clearance of Sugammadex From Blood | Second Dialysis (n=6) | 76.5 mL/min | Standard Deviation 19.6 |
| Sugammadex | Rate of Clearance of Sugammadex From Blood | First Dialysis (n=5) | 79.1 mL/min | Standard Deviation 19 |
| Sugammadex | Rate of Clearance of Sugammadex From Blood | Third Dialysis (n=4) | 72.4 mL/min | Standard Deviation 18.4 |
| Sugammadex | Rate of Clearance of Sugammadex From Blood | Fourth Dialysis (n=4) | 83.4 mL/min | Standard Deviation 16.5 |
Primary
Rate of Clearance of Sugammadex From Dialysate
Starting on Day 1 dialysis was performed on four separate occasions using a Fresenius 40008H hemodialyzer, with a hemodiafilter standard helixone membrane FX 600. Dialysate samples were collected from a port in the outflow of the dialyzer before, during and after an average of 6 hours of hemodialysis. The concentrations of sugammadex were determined using a liquid chromatographic assay with mass spectrometric detection. The clearance rate from dialysate at each dialysis session was assessed by averaging across all available collection time points.The data from the fourth dialysis are not presented as they were not calculable.
Time frame: Up to day 7
Population: All subjects pharmacokinetically evaluable consisting of all participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Rate of Clearance of Sugammadex From Dialysate | First Dialysis (n=5) | 63.0 mL/min | Standard Deviation 8.74 |
| Sugammadex | Rate of Clearance of Sugammadex From Dialysate | Second Dialysis (n=6) | 65.1 mL/min | Standard Deviation 7.06 |
| Sugammadex | Rate of Clearance of Sugammadex From Dialysate | Third Dialysis (n=4) | 66.8 mL/min | Standard Deviation 13.2 |
Secondary
Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium
Evidence of AEs due to possible interaction of sugammadex with endogenous compounds or with exogenous compounds other than rocuronium
Time frame: Day 1
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Number of Participants With Events Due to Possible Interaction of Sugammadex With Endo-/Exogenous Compounds Other Than Rocuronium | 0 participants |
Secondary
Number of Participants With Medical Device (Near) Incidents
A medical device (near) incident is defined as an occurrence due to inaccurate or inadequate labeling/instructions, or information supplied with a medical device; or malfunction, deterioration or recall of a medical device that could lead to death or serious deterioration in health.
Time frame: Up to day 7
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Number of Participants With Medical Device (Near) Incidents | 0 participants |
Secondary
Number of Participants With Physical Examinations
Physical examinations were to be conducted at screening, on Day 1 and 7 days after surgery
Time frame: Screening up to day 7
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sugammadex | Number of Participants With Physical Examinations | Screening | 6 participants |
| Sugammadex | Number of Participants With Physical Examinations | Peri-procedural (Day 1) | 6 participants |
| Sugammadex | Number of Participants With Physical Examinations | Day 7 | 0 participants |
Secondary
Number of Participants With Pregnancies at 30 Days Post-dose
Pregnancies reported by means of a Pregnancy Reporting Form, consist of pregnant female participants or pregnant female partners of male participants
Time frame: Up to 30 days post -dose
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Number of Participants With Pregnancies at 30 Days Post-dose | 0 participants |
Secondary
Number of Participants With Pre-treatment Adverse Events (AEs)
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body, whether or not related to the use of a product.
Time frame: Screening up to Day 1
Population: All Subjects Treated (AST) consisting of participants who received a dose of sugammadex
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Number of Participants With Pre-treatment Adverse Events (AEs) | 1 participants |
Secondary
Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1
Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery. Reoccurrence of neuromuscular blockade is defined as a decline in the T4/T1 ratio from \>= 0.9 to \< 0.8 in at least three consecutive measurements.
Time frame: Day 1
Population: AST consisting of all screened participants who received a dose of sugammadex
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Number of Participants With Reoccurrence of Neuromuscular Blockade at Day 1 | 0 participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose results in the following: death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Time frame: Up to day 7
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sugammadex | Number of Participants With Serious Adverse Events (SAEs) | 2 participants |
Secondary
Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.7. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.
Time frame: Day 1
Population: ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Sugammadex | Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.7 | 3.41 Minutes |
Secondary
Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the T1 and T4 response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.8. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.
Time frame: Day 1
Population: ITT group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Sugammadex | Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.8 | 4.05 Minutes |
Secondary
Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9
Neuromuscular function was monitored by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing the magnitudes (heights) of the first twitch (T1) and fourth twitch (T4) response at the adductor pollicis muscle with a TOF-Watch® SX. Stimulation continued until the T4/T1 ratio reached at least 0.9. Higher T4/T1 ratios represent greater recovery from neuromuscular blockade; with a value of 1.0 representing full recovery.
Time frame: Day 1
Population: Intent To Treat (ITT) group consisting of participants who received a dose of sugammadex and had at least one efficacy measurement
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Sugammadex | Time From Start of Administration of Sugammadex to Recovery of T4/T1 Ratio to 0.9 | 5.11 Minutes |
Secondary
Vital Sign: Mean Diastolic Blood Pressure
Diastolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery
Time frame: Screening up to 1 day after surgery
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | Screening | 58.2 mm Hg | Standard Deviation 6.2 |
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | Pre-Rocuronium | 51.2 mm Hg | Standard Deviation 13.6 |
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | Baseline pre-sugammadex | 45.2 mm Hg | Standard Deviation 13.3 |
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | 2 minutes post-sugammadex | 46.5 mm Hg | Standard Deviation 12.3 |
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | 5 minutes post-sugammadex | 44.5 mm Hg | Standard Deviation 12.1 |
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | 10 minutes post-sugammadex | 46.8 mm Hg | Standard Deviation 8.9 |
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | 30 minutes post-sugammadex | 43.7 mm Hg | Standard Deviation 9.4 |
| Sugammadex | Vital Sign: Mean Diastolic Blood Pressure | Post-anesthetic | 67.8 mm Hg | Standard Deviation 13.2 |
Secondary
Vital Sign: Mean Heart Rate
Heart rate was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery
Time frame: Screening up to 1 day after surgery
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Vital Sign: Mean Heart Rate | Screening | 81.7 Beats per minute | Standard Deviation 22.6 |
| Sugammadex | Vital Sign: Mean Heart Rate | Pre-Rocuronium | 78.0 Beats per minute | Standard Deviation 21.4 |
| Sugammadex | Vital Sign: Mean Heart Rate | Baseline pre-sugammadex | 83.7 Beats per minute | Standard Deviation 21.4 |
| Sugammadex | Vital Sign: Mean Heart Rate | 2 minutes post-sugammadex | 81.0 Beats per minute | Standard Deviation 20.8 |
| Sugammadex | Vital Sign: Mean Heart Rate | 5 minutes post-sugammadex | 80.5 Beats per minute | Standard Deviation 20.4 |
| Sugammadex | Vital Sign: Mean Heart Rate | 10 minutes post-sugammadex | 80.2 Beats per minute | Standard Deviation 20.4 |
| Sugammadex | Vital Sign: Mean Heart Rate | 30 minutes post-sugammadex | 77.8 Beats per minute | Standard Deviation 20.1 |
| Sugammadex | Vital Sign: Mean Heart Rate | Post-anesthetic | 71.8 Beats per minute | Standard Deviation 11.1 |
Secondary
Vital Sign: Mean Systolic Blood Pressure
Systolic blood pressure was measured at the following time points: screening, before rocuronium treatment, before sugammadex treatment, at 2, 5, 10, 20 minutes post-sugammadex treatment, and the day after surgery
Time frame: Screening up to 1 day after surgery
Population: AST consisting of all participants who received a dose of sugammadex
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | Screening | 124.2 mm Hg | Standard Deviation 19.2 |
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | Pre-Rocuronium | 106.3 mm Hg | Standard Deviation 25.2 |
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | Baseline pre-sugammadex | 105.5 mm Hg | Standard Deviation 20.4 |
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | 2 minutes post-sugammadex | 105.0 mm Hg | Standard Deviation 11.5 |
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | 5 minutes post-sugammadex | 103.2 mm Hg | Standard Deviation 10 |
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | 10 minutes post-sugammadex | 98.0 mm Hg | Standard Deviation 10.9 |
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | 30 minutes post-sugammadx | 92.8 mm Hg | Standard Deviation 21.3 |
| Sugammadex | Vital Sign: Mean Systolic Blood Pressure | Post-anesthetic | 146.3 mm Hg | Standard Deviation 26.7 |