Trial Outcomes & Findings for Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960) (NCT NCT00451217)
NCT ID: NCT00451217
Last Updated: 2019-03-04
Results Overview
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
198 participants
Primary outcome timeframe
Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9
Results posted on
2019-03-04
Participant Flow
Participants who had a surgical procedure using a general anesthesia of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block were enrolled in this study.
Participant milestones
| Measure |
Rocuronium + Sugammadex
After the last dose of rocuronium, at reappearance of second twitch (T2), a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
51
|
49
|
|
Overall Study
Treated
|
48
|
48
|
48
|
45
|
|
Overall Study
COMPLETED
|
47
|
47
|
47
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
5
|
Reasons for withdrawal
| Measure |
Rocuronium + Sugammadex
After the last dose of rocuronium, at reappearance of second twitch (T2), a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Not Treated
|
1
|
1
|
3
|
4
|
Baseline Characteristics
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
Baseline characteristics by cohort
| Measure |
Rocuronium + Sugammadex
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=45 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 Years
STANDARD_DEVIATION 16 • n=99 Participants
|
48 Years
STANDARD_DEVIATION 14 • n=107 Participants
|
49 Years
STANDARD_DEVIATION 16 • n=206 Participants
|
50 Years
STANDARD_DEVIATION 15 • n=7 Participants
|
49 Years
STANDARD_DEVIATION 15 • n=31 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
87 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
102 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
160 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
187 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade (NMB). In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.9 indicates a faster recovery from NMB.
Outcome measures
| Measure |
Rocuronium + Sugammadex
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=45 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
|
1.62 Minutes
Standard Deviation 0.83
|
26.78 Minutes
Standard Deviation 24.60
|
4.47 Minutes
Standard Deviation 9.28
|
23.43 Minutes
Standard Deviation 18.53
|
SECONDARY outcome
Timeframe: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.7 indicates a faster recovery from NMB.
Outcome measures
| Measure |
Rocuronium + Sugammadex
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=45 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7
|
1.17 Minutes
Standard Deviation 0.40
|
9.60 Minutes
Standard Deviation 8.23
|
1.68 Minutes
Standard Deviation 0.57
|
9.52 Minutes
Standard Deviation 10.15
|
SECONDARY outcome
Timeframe: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. Imputed recovery times were used in cases of missing times.
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 Ratio to 0.8 indicates a faster recovery from NMB.
Outcome measures
| Measure |
Rocuronium + Sugammadex
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=45 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8
|
1.32 Minutes
Standard Deviation 0.48
|
15.32 Minutes
Standard Deviation 14.38
|
2.12 Minutes
Standard Deviation 0.87
|
15.33 Minutes
Standard Deviation 13.37
|
SECONDARY outcome
Timeframe: Day 1Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement.
After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Outcome measures
| Measure |
Rocuronium + Sugammadex
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=45 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
Consciousness: Awake and oriented
|
30 Participants
|
35 Participants
|
29 Participants
|
26 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
Consciousness: Arousable with minimal stimulation
|
16 Participants
|
13 Participants
|
17 Participants
|
14 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
Consciousness: Responsive only to tactile stimuli
|
2 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
Able to perform the 5 second head lift
|
38 Participants
|
37 Participants
|
40 Participants
|
32 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
Has general muscle weakness
|
3 Participants
|
9 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: All randomized participants who received sugammadex or neostigmine and had at least one efficacy measurement. One participant from the Rocuronium + Sugammadex treatment group, and one participant from the Vecuronium + Neostigmine treatment group were not analyzed.
Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Outcome measures
| Measure |
Rocuronium + Sugammadex
n=47 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 Participants
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=44 Participants
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Consciousness: Awake and oriented
|
46 Participants
|
48 Participants
|
48 Participants
|
43 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Consciousness: Arousable with minimal stimulation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Consciousness: Responsive only to tactile stimuli
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Able to perform the 5 second head lift
|
47 Participants
|
48 Participants
|
48 Participants
|
44 Participants
|
|
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Has general muscle weakness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Rocuronium + Sugammadex
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Rocuronium + Neostigmine
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Vecuronium + Sugammadex
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Vecuronium + Neostigmine
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rocuronium + Sugammadex
n=48 participants at risk
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 participants at risk
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 participants at risk
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=45 participants at risk
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/45 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Infections and infestations
Postoperative infection
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/45 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
4.2%
2/48 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/45 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/45 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/45 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/45 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
Other adverse events
| Measure |
Rocuronium + Sugammadex
n=48 participants at risk
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Rocuronium + Neostigmine
n=48 participants at risk
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
Vecuronium + Sugammadex
n=48 participants at risk
After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered
|
Vecuronium + Neostigmine
n=45 participants at risk
After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
12.5%
6/48 • Number of events 6 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
4.2%
2/48 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.7%
3/45 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
3/48 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
10.4%
5/48 • Number of events 5 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
15.6%
7/45 • Number of events 7 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Gastrointestinal disorders
Nausea
|
25.0%
12/48 • Number of events 13 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
29.2%
14/48 • Number of events 17 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
27.1%
13/48 • Number of events 13 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
35.6%
16/45 • Number of events 19 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
9/48 • Number of events 9 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
12.5%
6/48 • Number of events 6 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
10.4%
5/48 • Number of events 6 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
11.1%
5/45 • Number of events 6 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
General disorders
Chills
|
4.2%
2/48 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
8.3%
4/48 • Number of events 4 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
8.3%
4/48 • Number of events 4 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
4.4%
2/45 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
General disorders
Pain
|
22.9%
11/48 • Number of events 12 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
16.7%
8/48 • Number of events 8 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
12.5%
6/48 • Number of events 7 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
11.1%
5/45 • Number of events 5 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.7%
3/45 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Neuromuscular block prolonged
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
8.9%
4/45 • Number of events 4 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Post procedural nausea
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.2%
3/48 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.7%
3/45 • Number of events 4 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Post procedural vomiting
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.7%
3/45 • Number of events 4 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Procedural complication
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
8.9%
4/45 • Number of events 5 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
8.3%
4/48 • Number of events 5 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.2%
3/48 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.2%
3/48 • Number of events 5 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.7%
3/45 • Number of events 7 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
10.4%
5/48 • Number of events 5 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.7%
3/45 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Injury, poisoning and procedural complications
Procedural pain
|
43.8%
21/48 • Number of events 26 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
33.3%
16/48 • Number of events 17 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
37.5%
18/48 • Number of events 21 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
35.6%
16/45 • Number of events 17 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.7%
3/45 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Nervous system disorders
Headache
|
6.2%
3/48 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
4.2%
2/48 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.2%
3/48 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
11.1%
5/45 • Number of events 5 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/48 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.2%
3/48 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
0.00%
0/45 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Psychiatric disorders
Sleep disorder
|
4.2%
2/48 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
6.2%
3/48 • Number of events 3 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.2%
1/45 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.3%
4/48 • Number of events 4 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
8.3%
4/48 • Number of events 4 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
2.1%
1/48 • Number of events 1 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
4.4%
2/45 • Number of events 2 • Up to 7 days after sugammadex or neostigmine treatment
All participants as treated
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any scientific paper, presentation, or other communication concerning the clinical trial described in this protocol will first be submitted to the Sponsor, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER