UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012495
Receipt No. R000014515
Scientific Title Mask ventilation under general anesthesia: Influences of muscle relaxant
Date of disclosure of the study information 2013/12/05
Last modified on 2019/05/16

* 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 Mask ventilation under general anesthesia: Influences of muscle relaxant
Acronym Mask ventilation and muscle relaxant
Scientific Title Mask ventilation under general anesthesia: Influences of muscle relaxant
Scientific Title:Acronym Mask ventilation and muscle relaxant
Region
Japan

Condition
Condition Patients undergoing elective surgeries under general anesthesia including children and adults
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test a hypothesis that muscle paralysis improves mask ventilation during general anesthesia induction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of breaths achieving normal capnograph waveform
Key secondary outcomes tidal volume

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 rocuronium
Interventions/Control_2 normal saline
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective surgeries under general anesthesia
Key exclusion criteria Patients who require awake intubation, patients with full stomach, patients with severe co-mobidities, patients with allergy for propofol and/or rocuronium
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiroh Isono
Organization Graduate School of Medicine,Chiba University
Division name Department of Anesthesiology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL 043222-7171
Email shirohisono@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiroh Isono
Organization Graduate School of Medicine,Chiba University
Division name Department of Anesthesiology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email shirohisono@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology,Graduate School of Medicine,Chiba University
Institute
Department

Funding Source
Organization Grant form Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2013 Year 12 Month 05 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 35
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 Completed
Date of protocol fixation
2013 Year 11 Month 25 Day
Date of IRB
2013 Year 11 Month 25 Day
Anticipated trial start date
2013 Year 12 Month 06 Day
Last follow-up date
2019 Year 02 Month 14 Day
Date of closure to data entry
2019 Year 02 Month 14 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 12 Month 05 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.