UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006219
Receipt number 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 2024/03/02 09:26:58

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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



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



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 Kenichi
Middle name
Last name Masui

Organization

National Defense Medical College Hospital

Division name

Department of Anesthesiology

Zip code

359-8513

Address

Namiki 3-2, Tokorozawa, Saitama, Japan

TEL

04-2995-1511

Email

kenichi@masuinet.com


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Masui

Organization

National Defense Medical College

Division name

Department of Anesthesiology

Zip code

359-8513

Address

Namiki 3-2, Tokorozawa, Saitama

TEL

04-2995-1511

Homepage URL


Email

kenichi@masuinet.com


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



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

National Defense Medical College

Address

Namiki 3-2, Tokorozawa, Saitama, Japan

Tel

04-2995-1211

Email

honrinri@ndmc.ac.jp


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

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

76

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Under analysis

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

2011 Year 04 Month 01 Day

Anticipated trial start date

2011 Year 04 Month 13 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2026 Year 03 Month 31 Day

Date trial data considered complete

2026 Year 03 Month 31 Day

Date analysis concluded

2026 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 08 Month 23 Day

Last modified on

2024 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007363


Research Plan
Registered date File name
2021/03/07 研究計画書.同意書筋弛緩2.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name