Trial Outcomes & Findings for A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797) (NCT NCT00124735)
NCT ID: NCT00124735
Last Updated: 2016-08-24
Results Overview
Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four \[TOF\] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol \[PP\] data set)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
149 participants
Primary outcome timeframe
during surgery
Results posted on
2016-08-24
Participant Flow
Participant milestones
| Measure |
Rocuronium Bolus Maintenance - Neonate (BN)
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Infants (BI)
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Toddlers (BT)
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance -Children (BC)
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Adolescents (BA)
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Neonates (IN)
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Infants (II)
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Toddlers (IT)
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Children (IC)
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
8
|
18
|
21
|
19
|
7
|
6
|
20
|
25
|
20
|
|
Overall Study
COMPLETED
|
4
|
6
|
18
|
18
|
17
|
5
|
6
|
19
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
3
|
2
|
2
|
0
|
1
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Baseline characteristics by cohort
| Measure |
Rocuronium Bolus Maintenance - Neonate (BN)
n=5 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Infants (BI)
n=6 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Toddlers (BT)
n=18 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance -Children (BC)
n=18 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Adolescents (BA)
n=17 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Neonates (IN)
n=5 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Infants (II)
n=6 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Toddlers (IT)
n=19 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Children (IC)
n=23 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
n=20 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
19 Participants
n=6 Participants
|
23 Participants
n=114 Participants
|
20 Participants
|
137 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
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
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
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
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
11 Participants
n=114 Participants
|
12 Participants
|
52 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
12 Participants
n=114 Participants
|
8 Participants
|
85 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: during surgeryPopulation: Per protocol population
Total dose from administration of intubating dose to reappearance of T3 (the third twitch of a Train of Four \[TOF\] stimulation) after the last maintenance bolus dose or discontinuation of Zemuron (rocuronium) infusion (Per protocol \[PP\] data set)
Outcome measures
| Measure |
Rocuronium Bolus Maintenance - Neonate (BN)
n=3 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Infants (BI)
n=5 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Toddlers (BT)
n=13 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance -Children (BC)
n=14 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Adolescents (BA)
n=15 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Neonates (IN)
n=5 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Infants (II)
n=2 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Toddlers (IT)
n=12 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Children (IC)
n=19 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
n=15 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Total Dose of Zemuron (Rocuronium) Administered
|
0.91 mg/kg
Standard Deviation 0.17
|
0.78 mg/kg
Standard Deviation 0.07
|
0.86 mg/kg
Standard Deviation 0.18
|
0.81 mg/kg
Standard Deviation 0.10
|
0.96 mg/kg
Standard Deviation 0.16
|
1.01 mg/kg
Standard Deviation 0.37
|
0.84 mg/kg
Standard Deviation 0.15
|
1.00 mg/kg
Standard Deviation 0.25
|
1.26 mg/kg
Standard Deviation 0.78
|
0.99 mg/kg
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)Population: per-protocol population
The time it takes for the the T4 to T1 ratio to reach 70%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
Outcome measures
| Measure |
Rocuronium Bolus Maintenance - Neonate (BN)
n=2 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Infants (BI)
n=4 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Toddlers (BT)
n=10 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance -Children (BC)
n=13 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Adolescents (BA)
n=11 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Neonates (IN)
n=3 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Infants (II)
n=1 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Toddlers (IT)
n=9 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Children (IC)
n=15 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
n=13 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%
|
29.62 minutes
Standard Deviation 13.60
|
33.25 minutes
Standard Deviation 16.17
|
22.65 minutes
Standard Deviation 7.62
|
16.19 minutes
Standard Deviation 6.70
|
28.04 minutes
Standard Deviation 13.33
|
43.32 minutes
Standard Deviation 1.53
|
33.25 minutes
Standard Deviation 0.00
|
23.08 minutes
Standard Deviation 13.40
|
18.37 minutes
Standard Deviation 12.69
|
27.59 minutes
Standard Deviation 12.51
|
SECONDARY outcome
Timeframe: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)Population: per-protocol population
The time it takes for the the T4 to T1 ratio to reach 80%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
Outcome measures
| Measure |
Rocuronium Bolus Maintenance - Neonate (BN)
n=2 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Infants (BI)
n=3 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Toddlers (BT)
n=9 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance -Children (BC)
n=11 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Adolescents (BA)
n=11 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Neonates (IN)
n=3 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Infants (II)
n=1 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Toddlers (IT)
n=9 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Children (IC)
n=15 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
n=11 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%
|
36.62 minutes
Standard Deviation 17.14
|
43.58 minutes
Standard Deviation 21.47
|
32.39 minutes
Standard Deviation 12.84
|
20.43 minutes
Standard Deviation 9.79
|
35.75 minutes
Standard Deviation 19.43
|
57.83 minutes
Standard Deviation 12.33
|
44.75 minutes
Standard Deviation 0.00
|
29.47 minutes
Standard Deviation 16.65
|
21.82 minutes
Standard Deviation 14.57
|
35.45 minutes
Standard Deviation 17.02
|
SECONDARY outcome
Timeframe: after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)Population: per-protocol population
The time it takes for the the T4 to T1 ratio to reach 90%. The T4/T1 ratio is indicative of recovery. At complete recovery, the T4/T1 ratio is 1.0 (100%).
Outcome measures
| Measure |
Rocuronium Bolus Maintenance - Neonate (BN)
n=1 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Infants (BI)
n=3 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Toddlers (BT)
n=8 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance -Children (BC)
n=8 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Bolus Maintenance - Adolescents (BA)
n=7 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Neonates (IN)
n=1 Participants
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Infants (II)
n=1 Participants
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Toddlers (IT)
n=9 Participants
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Children (IC)
n=13 Participants
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
n=10 Participants
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%
|
28.25 minutes
Standard Deviation 0
|
53.66 minutes
Standard Deviation 14.58
|
45.31 minutes
Standard Deviation 18.20
|
23.09 minutes
Standard Deviation 10.90
|
49.25 minutes
Standard Deviation 31.73
|
52.25 minutes
Standard Deviation 0
|
50.75 minutes
Standard Deviation 0
|
37.86 minutes
Standard Deviation 18.46
|
28.02 minutes
Standard Deviation 21.46
|
38.68 minutes
Standard Deviation 16.08
|
Adverse Events
Rocuronium Bolus Maintenance
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Rocuronium Continuous Infusion Maintenance
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rocuronium Bolus Maintenance
n=64 participants at risk
Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).
|
Rocuronium Continuous Infusion Maintenance
n=73 participants at risk
Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)
|
|---|---|---|
|
Infections and infestations
postoperative wound infection
|
1.6%
1/64 • Number of events 1
All subjects who received rocuronium were included in the safety analyses. Information regarding adverse events were obtained by questioning or examining the subject. At each visit during the treatment period, all new complaints and symptoms were recorded.
|
0.00%
0/73
All subjects who received rocuronium were included in the safety analyses. Information regarding adverse events were obtained by questioning or examining the subject. At each visit during the treatment period, all new complaints and symptoms were recorded.
|
Other adverse events
| Measure |
Rocuronium Bolus Maintenance
n=64 participants at risk
Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).
|
Rocuronium Continuous Infusion Maintenance
n=73 participants at risk
Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)
|
|---|---|---|
|
Injury, poisoning and procedural complications
procedural pain
|
15.6%
10/64 • Number of events 12
All subjects who received rocuronium were included in the safety analyses. Information regarding adverse events were obtained by questioning or examining the subject. At each visit during the treatment period, all new complaints and symptoms were recorded.
|
12.3%
9/73 • Number of events 9
All subjects who received rocuronium were included in the safety analyses. Information regarding adverse events were obtained by questioning or examining the subject. At each visit during the treatment period, all new complaints and symptoms were recorded.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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 the protocol will first be submitted to Organon, at least 6 weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER