Trial Outcomes & Findings for Sugammadex as Rescue Therapy (NCT NCT05661409)
NCT ID: NCT05661409
Last Updated: 2025-09-05
Results Overview
The time taken to achieve a time of train (TOF) ratio of 0.9 after the use of the intervention drug versus placebo in a patient population that has already received neostigmine for NMB reversal. Quantitative neuromuscular monitoring will be carried out using electromyography, which measures the TOF ratio every 20 seconds. The TOF count (between 0 to 4) and the TOF ratio (0 to 1) would be measured and recorded at baseline and after administration of the study drug. If the TOF ratio remains \< 0.9 after this, or if the patient exhibits any symptoms or signs of residual NMB blockade, a further 2 mg/kg dose of sugammadex would be given until the patient achieves a TOF ratio of 0.9.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
10 minutes post administration of study drug
Results posted on
2025-09-05
Participant Flow
Participants were recruited from the Grady Memorial Hospital OR who were scheduled to undergo an elective surgery under general anesthesia, received rocuronium for NMB, and received neostigmine for NMB reversal, and achieved a TOF count of at least 3 twitches but had a TOF ratio less than 0.9 15 minutes after neostigmine had been given. Participant enrollment began on July 21, 2023, and the final study assessment occurred on August 2, 2024.
Participant milestones
| Measure |
Sugammadex 2 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 1 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.5 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.25 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.125 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Placebo
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
6
|
7
|
8
|
10
|
|
Overall Study
COMPLETED
|
7
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
2
|
4
|
Reasons for withdrawal
| Measure |
Sugammadex 2 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 1 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.5 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.25 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.125 mg/kg
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Placebo
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
|---|---|---|---|---|---|---|
|
Overall Study
Drug administered, but monitor disconnected
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
No TOFR data; problem with the monitor
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
TOFR≥0.9 at time of drug admin.
|
0
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Lost TOFR data prior to time study drug given
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Miscommu-nication about administration
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Sugammadex as Rescue Therapy
Baseline characteristics by cohort
| Measure |
Sugammadex 2 mg/kg
n=7 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 1 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.5 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.25 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.125 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Placebo
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Train-of-four count (TOFC) before neostigmine
0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
56.7 years
STANDARD_DEVIATION 14.1 • n=21 Participants
|
44.8 years
STANDARD_DEVIATION 15.8 • n=8 Participants
|
53.0 years
STANDARD_DEVIATION 14.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
BMI
<20 kg/m^2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
BMI
20-29 kg/m^2
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
BMI
30-39 kg/m^2
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
ASA Status
ASA I
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
ASA Status
ASA II
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
ASA Status
ASA III
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
ASA Status
ASA IV
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Surgery duration
|
261 minutes
STANDARD_DEVIATION 81 • n=5 Participants
|
260 minutes
STANDARD_DEVIATION 96 • n=7 Participants
|
303 minutes
STANDARD_DEVIATION 103 • n=5 Participants
|
239 minutes
STANDARD_DEVIATION 70 • n=4 Participants
|
209 minutes
STANDARD_DEVIATION 74 • n=21 Participants
|
207 minutes
STANDARD_DEVIATION 77 • n=8 Participants
|
247 minutes
STANDARD_DEVIATION 85 • n=8 Participants
|
|
Total rocuronium
|
111 mg
STANDARD_DEVIATION 46 • n=5 Participants
|
84 mg
STANDARD_DEVIATION 44 • n=7 Participants
|
130 mg
STANDARD_DEVIATION 56 • n=5 Participants
|
113 mg
STANDARD_DEVIATION 24 • n=4 Participants
|
77 mg
STANDARD_DEVIATION 27 • n=21 Participants
|
82 mg
STANDARD_DEVIATION 28 • n=8 Participants
|
100 mg
STANDARD_DEVIATION 42 • n=8 Participants
|
|
Neostigmine dose
|
4.57 mg/kg
STANDARD_DEVIATION 0.53 • n=5 Participants
|
4.08 mg/kg
STANDARD_DEVIATION 1.43 • n=7 Participants
|
4.25 mg/kg
STANDARD_DEVIATION 0.99 • n=5 Participants
|
4.50 mg/kg
STANDARD_DEVIATION 0.84 • n=4 Participants
|
4.58 mg/kg
STANDARD_DEVIATION 0.80 • n=21 Participants
|
4.08 mg/kg
STANDARD_DEVIATION 1.11 • n=8 Participants
|
4.35 mg/kg
STANDARD_DEVIATION 0.93 • n=8 Participants
|
|
Time from last rocuronium to neostigmine
|
53.1 mins
STANDARD_DEVIATION 29.5 • n=5 Participants
|
59.0 mins
STANDARD_DEVIATION 44.3 • n=7 Participants
|
48.5 mins
STANDARD_DEVIATION 18.0 • n=5 Participants
|
63.7 mins
STANDARD_DEVIATION 24.6 • n=4 Participants
|
81.3 mins
STANDARD_DEVIATION 19.8 • n=21 Participants
|
58.5 mins
STANDARD_DEVIATION 51.5 • n=8 Participants
|
60.5 mins
STANDARD_DEVIATION 32.8 • n=8 Participants
|
|
Baseline train-of-four ratio TOFR (0-1)
|
1.00 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0 • n=21 Participants
|
0.99 units on a scale
STANDARD_DEVIATION 0.02 • n=8 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0.01 • n=8 Participants
|
|
Train-of-four count (TOFC) before neostigmine
1
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) before neostigmine
2
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) before neostigmine
3
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) before neostigmine
4 with fade
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) before neostigmine
4 without fade
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Train-of-four ratio (TOFR) before neostigmine (0-1)
|
0.04 units on a scale
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.00 units on a scale
STANDARD_DEVIATION 0.00 • n=7 Participants
|
0.06 units on a scale
STANDARD_DEVIATION 0.09 • n=5 Participants
|
0.00 units on a scale
STANDARD_DEVIATION 0.00 • n=4 Participants
|
0.04 units on a scale
STANDARD_DEVIATION 0.09 • n=21 Participants
|
0.02 units on a scale
STANDARD_DEVIATION 0.06 • n=8 Participants
|
0.03 units on a scale
STANDARD_DEVIATION 0.08 • n=8 Participants
|
|
Train-of-four count (TOFC) 15 mins after neostigmine
0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) 15 mins after neostigmine
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) 15 mins after neostigmine
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) 15 mins after neostigmine
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) 15 mins after neostigmine
4 with fade
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Train-of-four count (TOFC) 15 mins after neostigmine
4 without fade
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Train-of-four ratio (TOFR) before study drug (0-1)
|
0.47 units on a scale
STANDARD_DEVIATION 0.31 • n=5 Participants
|
0.57 units on a scale
STANDARD_DEVIATION 0.14 • n=7 Participants
|
0.65 units on a scale
STANDARD_DEVIATION 0.10 • n=5 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 0.32 • n=4 Participants
|
0.65 units on a scale
STANDARD_DEVIATION 0.14 • n=21 Participants
|
0.69 units on a scale
STANDARD_DEVIATION 0.21 • n=8 Participants
|
0.59 units on a scale
STANDARD_DEVIATION 0.22 • n=8 Participants
|
|
Train-of-four ratio (TOFR) 15 mins after neostigmine (0-1)
|
0.48 units on a scale
STANDARD_DEVIATION 0.30 • n=5 Participants
|
0.55 units on a scale
STANDARD_DEVIATION 0.14 • n=7 Participants
|
0.64 units on a scale
STANDARD_DEVIATION 0.12 • n=5 Participants
|
0.52 units on a scale
STANDARD_DEVIATION 0.32 • n=4 Participants
|
0.58 units on a scale
STANDARD_DEVIATION 0.21 • n=21 Participants
|
0.63 units on a scale
STANDARD_DEVIATION 0.20 • n=8 Participants
|
0.56 units on a scale
STANDARD_DEVIATION 0.22 • n=8 Participants
|
PRIMARY outcome
Timeframe: 10 minutes post administration of study drugThe time taken to achieve a time of train (TOF) ratio of 0.9 after the use of the intervention drug versus placebo in a patient population that has already received neostigmine for NMB reversal. Quantitative neuromuscular monitoring will be carried out using electromyography, which measures the TOF ratio every 20 seconds. The TOF count (between 0 to 4) and the TOF ratio (0 to 1) would be measured and recorded at baseline and after administration of the study drug. If the TOF ratio remains \< 0.9 after this, or if the patient exhibits any symptoms or signs of residual NMB blockade, a further 2 mg/kg dose of sugammadex would be given until the patient achieves a TOF ratio of 0.9.
Outcome measures
| Measure |
Sugammadex 2 mg/kg
n=7 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 1 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.5 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.25 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.125 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Placebo
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
|---|---|---|---|---|---|---|
|
The Time Taken to Achieve a TOF Ratio of 0.9 After Administration Sugammadex
|
3.13 minutes
Standard Deviation 3.15
|
2.56 minutes
Standard Deviation 0.96
|
2.33 minutes
Standard Deviation 0.84
|
5.00 minutes
Standard Deviation 3.97
|
4.94 minutes
Standard Deviation 2.64
|
9.67 minutes
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 1 minute, 2 minutes and 10 minutes post administration of study drugThe percentage of patients who achieve a TOF ratio of 0.9 will be measured within 1 minute, 2 minutes, 5 minutes, and 10 minutes after the administration of the study drug, sugammadex.
Outcome measures
| Measure |
Sugammadex 2 mg/kg
n=7 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 1 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.5 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.25 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.125 mg/kg
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Placebo
n=6 Participants
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
|---|---|---|---|---|---|---|
|
The Percentage of Patients Who Achieve a TOF Ratio of 0.9
in 1 min
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
The Percentage of Patients Who Achieve a TOF Ratio of 0.9
in 2 min
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
The Percentage of Patients Who Achieve a TOF Ratio of 0.9
in 5 min
|
6 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
The Percentage of Patients Who Achieve a TOF Ratio of 0.9
in 10 min
|
7 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
Adverse Events
Sugammadex 2 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sugammadex 1 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sugammadex 0.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugammadex 0.25 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sugammadex 0.125 mg/kg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sugammadex 2 mg/kg
n=7 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 1 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.5 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.25 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.125 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Placebo
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
|---|---|---|---|---|---|---|
|
General disorders
Hypotension
|
0.00%
0/7 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/7 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
Other adverse events
| Measure |
Sugammadex 2 mg/kg
n=7 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 1 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.5 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.25 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Sugammadex 0.125 mg/kg
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
Placebo
n=6 participants at risk
Patients were randomized to one of the six dose-based groups. The groups were differentiated based on dose given per kg of body weight
|
|---|---|---|---|---|---|---|
|
General disorders
Nausea
|
0.00%
0/7 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
50.0%
3/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/7 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
0.00%
0/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
33.3%
2/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
16.7%
1/6 • The time frame is up to the time the patient is transferred out of the PACU. This occurs when an anesthesiologist determines that the patient has recovered from anesthesia and typical durations are 1-2 hours.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place