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A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)

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ClinicalTrials.gov Identifier: NCT00124735
Recruitment Status : Completed
First Posted : July 28, 2005
Results First Posted : April 15, 2009
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anesthesia
Interventions Drug: Rocuronium bolus maintenance
Drug: rocuronium continuous infusion maintenance
Enrollment 149
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rocuronium Bolus Maintenance - Neonate (BN) Rocuronium Bolus Maintenance - Infants (BI) Rocuronium Bolus Maintenance - Toddlers (BT) Rocuronium Bolus Maintenance -Children (BC) Rocuronium Bolus Maintenance - Adolescents (BA) Rocuronium Continuous Infusion Maintenance - Neonates (IN) Rocuronium Continuous Infusion Maintenance - Infants (II) Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Rocuronium Continuous Infusion Maintenance - Children (IC) Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
Hide Arm/Group Description Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Period Title: Overall Study
Started 5 8 18 21 19 7 6 20 25 20
Completed 4 6 18 18 17 5 6 19 22 18
Not Completed 1 2 0 3 2 2 0 1 3 2
Arm/Group Title Rocuronium Bolus Maintenance - Neonate (BN) Rocuronium Bolus Maintenance - Infants (BI) Rocuronium Bolus Maintenance - Toddlers (BT) Rocuronium Bolus Maintenance -Children (BC) Rocuronium Bolus Maintenance - Adolescents (BA) Rocuronium Continuous Infusion Maintenance - Neonates (IN) Rocuronium Continuous Infusion Maintenance - Infants (II) Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Rocuronium Continuous Infusion Maintenance - Children (IC) Rocuronium Continuous Infusion Maintenance - Adolescents (IA) Total
Hide Arm/Group Description Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation Total of all reporting groups
Overall Number of Baseline Participants 5 6 18 18 17 5 6 19 23 20 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 18 participants 18 participants 17 participants 5 participants 6 participants 19 participants 23 participants 20 participants 137 participants
<=18 years
5
 100.0%
6
 100.0%
18
 100.0%
18
 100.0%
17
 100.0%
5
 100.0%
6
 100.0%
19
 100.0%
23
 100.0%
20
 100.0%
137
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Total of 137 subjects include all subjects who received rocuronium
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 18 participants 18 participants 17 participants 5 participants 6 participants 19 participants 23 participants 20 participants 137 participants
Female
2
  40.0%
1
  16.7%
1
   5.6%
8
  44.4%
6
  35.3%
2
  40.0%
3
  50.0%
6
  31.6%
11
  47.8%
12
  60.0%
52
  38.0%
Male
3
  60.0%
5
  83.3%
17
  94.4%
10
  55.6%
11
  64.7%
3
  60.0%
3
  50.0%
13
  68.4%
12
  52.2%
8
  40.0%
85
  62.0%
[1]
Measure Description: Total of 137 subjects include all subjects who received rocuronium
1.Primary Outcome
Title Total Dose of Zemuron (Rocuronium) Administered
Hide Description 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)
Time Frame during surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title Rocuronium Bolus Maintenance - Neonate (BN) Rocuronium Bolus Maintenance - Infants (BI) Rocuronium Bolus Maintenance - Toddlers (BT) Rocuronium Bolus Maintenance -Children (BC) Rocuronium Bolus Maintenance - Adolescents (BA) Rocuronium Continuous Infusion Maintenance - Neonates (IN) Rocuronium Continuous Infusion Maintenance - Infants (II) Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Rocuronium Continuous Infusion Maintenance - Children (IC) Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
Hide Arm/Group Description:
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Overall Number of Participants Analyzed 3 5 13 14 15 5 2 12 19 15
Mean (Standard Deviation)
Unit of Measure: mg/kg
0.91  (0.17) 0.78  (0.07) 0.86  (0.18) 0.81  (0.10) 0.96  (0.16) 1.01  (0.37) 0.84  (0.15) 1.00  (0.25) 1.26  (0.78) 0.99  (0.37)
2.Secondary Outcome
Title Duration of Recovery of T4/T1 Ratio (TOF Fourth Twitch to First Twitch) 70%
Hide Description 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%).
Time Frame after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Hide Outcome Measure Data
Hide Analysis Population Description
per-protocol population
Arm/Group Title Rocuronium Bolus Maintenance - Neonate (BN) Rocuronium Bolus Maintenance - Infants (BI) Rocuronium Bolus Maintenance - Toddlers (BT) Rocuronium Bolus Maintenance -Children (BC) Rocuronium Bolus Maintenance - Adolescents (BA) Rocuronium Continuous Infusion Maintenance - Neonates (IN) Rocuronium Continuous Infusion Maintenance - Infants (II) Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Rocuronium Continuous Infusion Maintenance - Children (IC) Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
Hide Arm/Group Description:
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Overall Number of Participants Analyzed 2 4 10 13 11 3 1 9 15 13
Mean (Standard Deviation)
Unit of Measure: minutes
29.62  (13.60) 33.25  (16.17) 22.65  (7.62) 16.19  (6.70) 28.04  (13.33) 43.32  (1.53) 33.25  (0.00) 23.08  (13.40) 18.37  (12.69) 27.59  (12.51)
3.Secondary Outcome
Title Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 80%
Hide Description 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%).
Time Frame after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Hide Outcome Measure Data
Hide Analysis Population Description
per-protocol population
Arm/Group Title Rocuronium Bolus Maintenance - Neonate (BN) Rocuronium Bolus Maintenance - Infants (BI) Rocuronium Bolus Maintenance - Toddlers (BT) Rocuronium Bolus Maintenance -Children (BC) Rocuronium Bolus Maintenance - Adolescents (BA) Rocuronium Continuous Infusion Maintenance - Neonates (IN) Rocuronium Continuous Infusion Maintenance - Infants (II) Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Rocuronium Continuous Infusion Maintenance - Children (IC) Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
Hide Arm/Group Description:
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Overall Number of Participants Analyzed 2 3 9 11 11 3 1 9 15 11
Mean (Standard Deviation)
Unit of Measure: minutes
36.62  (17.14) 43.58  (21.47) 32.39  (12.84) 20.43  (9.79) 35.75  (19.43) 57.83  (12.33) 44.75  (0.00) 29.47  (16.65) 21.82  (14.57) 35.45  (17.02)
4.Secondary Outcome
Title Duration of Recovery of T4/T1 (TOF Fourth Twitch to First Twitch) Ratio 90%
Hide Description 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%).
Time Frame after surgery, from the reappearance of T3 after Zemuron(R) (rocuronium) infusion/last bolus dose of Zemuron(R) (rocuronium)
Hide Outcome Measure Data
Hide Analysis Population Description
per-protocol population
Arm/Group Title Rocuronium Bolus Maintenance - Neonate (BN) Rocuronium Bolus Maintenance - Infants (BI) Rocuronium Bolus Maintenance - Toddlers (BT) Rocuronium Bolus Maintenance -Children (BC) Rocuronium Bolus Maintenance - Adolescents (BA) Rocuronium Continuous Infusion Maintenance - Neonates (IN) Rocuronium Continuous Infusion Maintenance - Infants (II) Rocuronium Continuous Infusion Maintenance - Toddlers (IT) Rocuronium Continuous Infusion Maintenance - Children (IC) Rocuronium Continuous Infusion Maintenance - Adolescents (IA)
Hide Arm/Group Description:
Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
Overall Number of Participants Analyzed 1 3 8 8 7 1 1 9 13 10
Mean (Standard Deviation)
Unit of Measure: minutes
28.25  (0) 53.66  (14.58) 45.31  (18.20) 23.09  (10.90) 49.25  (31.73) 52.25  (0) 50.75  (0) 37.86  (18.46) 28.02  (21.46) 38.68  (16.08)
Time Frame [Not Specified]
Adverse Event Reporting Description

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.

 
Arm/Group Title Rocuronium Bolus Maintenance Rocuronium Continuous Infusion Maintenance
Hide Arm/Group Description 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). 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)
All-Cause Mortality
Rocuronium Bolus Maintenance Rocuronium Continuous Infusion Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rocuronium Bolus Maintenance Rocuronium Continuous Infusion Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/64 (1.56%)      0/73 (0.00%)    
Infections and infestations     
postoperative wound infection  1  1/64 (1.56%)  1 0/73 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rocuronium Bolus Maintenance Rocuronium Continuous Infusion Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/64 (15.63%)      9/73 (12.33%)    
Injury, poisoning and procedural complications     
procedural pain  1  10/64 (15.63%)  12 9/73 (12.33%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
Bhattacharya ST, Jeffrey Koh J, Martin L, Suresh S, Frietsch T. Randomized, Multicenter Trial of Rocuronium in Neonates, Infants, Toddlers, Children & Adolescents [abstract]. Anesthesiology. 2009;111(5):A841.
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00124735    
Other Study ID Numbers: P05797
21048
First Submitted: July 26, 2005
First Posted: July 28, 2005
Results First Submitted: December 5, 2008
Results First Posted: April 15, 2009
Last Update Posted: August 24, 2016