UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034556
Receipt No. R000039394
Scientific Title Effects of preoperative amino acid infusion on the duration of Rocuronium during laparotomy (non-randomized comparative study)
Date of disclosure of the study information 2018/10/18
Last modified on 2018/10/18

* 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 Effects of preoperative amino acid infusion on the duration of Rocuronium during laparotomy (non-randomized comparative study)
Acronym Effects of amino acid infusion on the duration of Rocuronium
Scientific Title Effects of preoperative amino acid infusion on the duration of Rocuronium during laparotomy (non-randomized comparative study)
Scientific Title:Acronym Effects of amino acid infusion on the duration of Rocuronium
Region
Japan

Condition
Condition laparotomy
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Effect of preoperative amino acid infusion on the duration of Rocuronium during laparotomy
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes duration of Rocuronium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 amino acid infusion group
Interventions/Control_2 placebo (saline) control
Interventions/Control_3
Interventions/Control_4
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

Not applicable
Gender Male and Female
Key inclusion criteria patients scheduled laparotomy(malignant & non-malignant diseases)
Key exclusion criteria patients taking drugs which affect the duration of Rocuronium
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Watanabe
Organization National Health Organization Mito Medical Center
Division name Department of Anesthesiology
Zip code
Address Sakuranosato 280, Ibaraki City, IBARAKI
TEL 029-240-7711
Email atenza.kazuhirowatanabe@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Watanabe
Organization National Health Organization Mito Medical Center
Division name Department of Anesthesiology
Zip code
Address Sakuranosato 280, Ibaraki City, IBARAKI
TEL 029-240-7711
Homepage URL
Email atenza.kazuhirowatanabe@gmail.com

Sponsor
Institute Division of Clinical Research
National Health Organization
Mito Medical Center
Institute
Department

Funding Source
Organization Division of Clinical Research
National Health Organization
Mito Medical Center
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
2018 Year 10 Month 18 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
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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 18 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
2018 Year 10 Month 18 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039394

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.