Trial Outcomes & Findings for Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children (NCT NCT03943888)
NCT ID: NCT03943888
Last Updated: 2022-11-14
Results Overview
Time to recovery of train-of-four T4/T1 ratio to 90% after sugammadex sodium or neuromuscular reversal agent administration up to 30 minutes to 1 hour.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
up to 30 minutes to 1 hour
Results posted on
2022-11-14
Participant Flow
Participant milestones
| Measure |
Sugammadex 2mg
Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 4mg
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 8mg
Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Conventional Reversal
Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children
Baseline characteristics by cohort
| Measure |
Sugammadex 2mg
n=10 Participants
Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 4mg
n=10 Participants
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 8mg
n=10 Participants
Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Conventional Reversal
n=10 Participants
Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
40 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Continuous
|
6.5 years
n=39 Participants
|
10 years
n=41 Participants
|
6 years
n=35 Participants
|
8.5 years
n=31 Participants
|
7 years
n=146 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
19 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
21 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
40 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
South Korea
|
10 participants
n=39 Participants
|
10 participants
n=41 Participants
|
10 participants
n=35 Participants
|
10 participants
n=31 Participants
|
40 participants
n=146 Participants
|
|
Type of surgery
Brain
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
27 Participants
n=146 Participants
|
|
Type of surgery
Spine
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
13 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: up to 30 minutes to 1 hourTime to recovery of train-of-four T4/T1 ratio to 90% after sugammadex sodium or neuromuscular reversal agent administration up to 30 minutes to 1 hour.
Outcome measures
| Measure |
Sugammadex 2mg
n=10 Participants
Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 4mg
n=10 Participants
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 8mg
n=10 Participants
Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Conventional Reversal
n=10 Participants
Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
|
|---|---|---|---|---|
|
Neuromuscular Recovery
|
5.7 Minutes
Standard Deviation 4.7
|
3.1 Minutes
Standard Deviation 1.0
|
1.1 Minutes
Standard Deviation 1.0
|
43.7 Minutes
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: From anesthetic induction to 480 minutes after sugammadex administrationPopulation: Cmax of sugammadex and rocuronium
Plasma concentrations of rocuronium and sugammadex sodium
Outcome measures
| Measure |
Sugammadex 2mg
n=10 Participants
Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 4mg
n=10 Participants
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Sugammadex 8mg
n=10 Participants
Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
|
Conventional Reversal
n=10 Participants
Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Neuromuscular reversal agent injection: Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
|
|---|---|---|---|---|
|
Plasma Concentrations
Sugammadex
|
28.5 mcg/mL
Standard Deviation 9.6
|
58.2 mcg/mL
Standard Deviation 12.5
|
118.9 mcg/mL
Standard Deviation 13
|
—
|
|
Plasma Concentrations
Rocuronium
|
5.3 mcg/mL
Standard Deviation 1.9
|
8.0 mcg/mL
Standard Deviation 2.1
|
5.4 mcg/mL
Standard Deviation 3
|
6.8 mcg/mL
Standard Deviation 3.1
|
Adverse Events
Sugammadex 2mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugammadex 4mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sugammadex 8mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Reversal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place