UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012495
Receipt number 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 17:09:59

* 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 or person

Institute

Department of Anesthesiology,Graduate School of Medicine,Chiba University

Institute

Department

Personal name



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

Value
https://center6.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