UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006219
Receipt No. R000007363
Scientific Title Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Date of disclosure of the study information 2011/08/23
Last modified on 2016/08/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Acronym Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Scientific Title Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Scientific Title:Acronym Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Region
Japan

Condition
Condition patient undergoing elective surgery under general anesthesia
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to examine the effect of infusion method of neuromuscular blockade on pharmacokinetics and pharmacodynamics of neuromuscular blockade.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pharmacodynamic effect of neuromuscular blockade
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 rocuronium 0.6 mg/kg is administered at 1 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
Interventions/Control_2 rocuronium 0.6 mg/kg is administered at 0.75 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
Interventions/Control_3 rocuronium 0.6 mg/kg is administered at 0.5 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
Interventions/Control_4 rocuronium 0.6 mg/kg is administered at 0.25 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria patients undergoing elective surgery under general anesthesia
Key exclusion criteria significant heart, respiratory, hepatic, or renal impairment; neuromuscular disease; body mass index greater than 30
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Masui
Organization National Defense Medical College Hospital
Division name Department of Anesthesiology
Zip code
Address Namiki 3-2, Tokorozawa, Saitama, Japan
TEL 04-2995-1511
Email kenichi@masuinet.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Masui
Organization National Defense Medical College
Division name Department of Anesthesiology
Zip code
Address Namiki 3-2, Tokorozawa, Saitama
TEL 04-2995-1511
Homepage URL
Email kenichi@masuinet.com

Sponsor
Institute National Defense Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization National Defense Medical College and
Departmental Funding
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 23 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 08 Month 23 Day
Last modified on
2016 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007363


Contact us.