Trial Outcomes & Findings for Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698) (NCT NCT00535496)
NCT ID: NCT00535496
Last Updated: 2015-03-17
Results Overview
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
COMPLETED
PHASE3
91 participants
Up to 4 minutes after administering sugammadex
2015-03-17
Participant Flow
Participant milestones
| Measure |
Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
|
Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
|
Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
|
Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
30
|
31
|
|
Overall Study
All-Subjects-Treated (AST) Group
|
15
|
14
|
30
|
31
|
|
Overall Study
COMPLETED
|
15
|
13
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
|
Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
|
Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
|
Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Not treated with sugammadex
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)
Baseline characteristics by cohort
| Measure |
Sugammadex 1.0 mg/kg
n=29 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
n=61 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 11 • n=99 Participants
|
42 years
STANDARD_DEVIATION 13 • n=107 Participants
|
42 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 4 minutes after administering sugammadexPopulation: The Intent-To-Treat (ITT) population: randomized, received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed.The 1.0 mg/kg group was not evaluated.
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=60 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX
|
1.5 Minutes
Standard Deviation 0.7 • Interval 82.0 to 102.0
|
—
|
PRIMARY outcome
Timeframe: up to 2 minutes after administering sugammadexPopulation: The ITT population consisting of all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 1.0 mg/kg were not evaluated for this outcome measure.
Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=61 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)
|
0.8 Minutes
Standard Deviation 0.3 • Interval 42.0 to 50.0
|
—
|
PRIMARY outcome
Timeframe: Up to 3 minutes after administering sugammadexPopulation: The ITT population: all randomized participants who received 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias; their differences were not analyzed. One participant who did not reach a T4/T1 ratio of 0.9 was not analyzed. The 1.0 mg/kg group was not evaluated.
The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=60 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex
|
0.8 Minutes
95% Confidence Interval 0.6 • Interval 0.6 to 0.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 150 minutes after administering sugammadexPopulation: The ITT population: randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. One participant was not analyzed as the time of recovery was judged unreliable. The 4.0 mg/kg group was not evaluated.
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 1.0 mg/kg sugammadex are presented where the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=28 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Time From Start of Administration of 1.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX
|
17.2 Minutes
Standard Deviation 28.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 7 minutes after administering sugammadexPopulation: The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T4 is the fourth twitch after TOF nerve stimulation. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=29 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
n=61 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a TOF-Watch® SX
|
2.1 Minutes
Standard Deviation 1.6
|
0.8 Minutes
Standard Deviation 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 minutes after administering sugammadexPopulation: The ITT population consisting of all randomized participants who received 1.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed. Participants treated with 4.0 mg/kg were not evaluated for this outcome measure.
Neuromuscular function was monitored by applying repetitive TOF stimulations manually to the ulnar nerve of one forearm every 15 seconds \& the number of twitches collected manually at the adductor pollicis muscle with the PNS by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 1.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =15, and on the non-dominant forearm n = 14. The 4.0 mg/kg sugammadex group was not evaluated for this outcome measure.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=29 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Time From Start of Administration of 1.0 mg/kg Sugammadex to Reappearance of T4 Measured by a PNS
|
1.7 Minutes
Standard Deviation 1.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 minutes after administering sugammadexPopulation: The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.8. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=29 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
n=61 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.8 Measured by a TOF-Watch® SX
|
9.9 Minutes
Standard Deviation 11.4
|
1.3 Minutes
Standard Deviation 1.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 42 minutes after administering sugammadexPopulation: The ITT population consisting of all randomized participants who received 1.0 or 4.0 mg/kg sugammadex, and had at least one efficacy measurement. As dominant and non-dominant forearms were aimed at preventing bias, their differences were not analyzed.
Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.7. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. For participants treated with 1.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =15, and on the non-dominant forearm n = 14. For participants treated with 4.0 mg/kg sugammadex the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31.
Outcome measures
| Measure |
Sugammadex 4.0 mg/kg
n=29 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
n=61 Participants
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.7 Measured by a TOF-Watch® SX
|
7.6 Minutes
Standard Deviation 10.2
|
1.1 Minutes
Standard Deviation 0.9
|
Adverse Events
Sugammadex 1.0 mg/kg
Sugammadex 4.0 mg/kg
Serious adverse events
| Measure |
Sugammadex 1.0 mg/kg
n=29 participants at risk
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
n=61 participants at risk
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/29 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
1.6%
1/61 • Number of events 1 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Hepatobiliary disorders
Perforation bile duct
|
0.00%
0/29 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
1.6%
1/61 • Number of events 1 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/29 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
1.6%
1/61 • Number of events 1 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/29 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
1.6%
1/61 • Number of events 1 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
1.6%
1/61 • Number of events 1 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/29 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
1.6%
1/61 • Number of events 1 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
Other adverse events
| Measure |
Sugammadex 1.0 mg/kg
n=29 participants at risk
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
Sugammadex 4.0 mg/kg
n=61 participants at risk
Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
27.6%
8/29 • Number of events 8 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
31.1%
19/61 • Number of events 19 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.7%
6/29 • Number of events 6 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
14.8%
9/61 • Number of events 10 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
27.6%
8/29 • Number of events 9 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
27.9%
17/61 • Number of events 18 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
3.4%
1/29 • Number of events 1 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
6.6%
4/61 • Number of events 4 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/29 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
6.6%
4/61 • Number of events 4 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
6.9%
2/29 • Number of events 2 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
6.6%
4/61 • Number of events 4 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
41.4%
12/29 • Number of events 14 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
50.8%
31/61 • Number of events 35 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
|
Injury, poisoning and procedural complications
Underdose
|
24.1%
7/29 • Number of events 7 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
0.00%
0/61 • From screening period up to and including seventh post-operative day
All Patients Treated. One participant from the 1.0 mg/kg sugammadex group was not treated, and discontinued from the study.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Any scientific paper, presentation, or other communication concerning the clinical trial will first be submitted at least six weeks ahead of publication or presentation, for written consent. The Sponsor shall have the right to make its consent conditional upon proper representation of the interpretation and discussion of the data.
- Publication restrictions are in place
Restriction type: OTHER