UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027403
Receipt number R000031407
Scientific Title Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient
Date of disclosure of the study information 2017/05/19
Last modified on 2020/11/25 16:05:42

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Basic information

Public title

Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient

Acronym

Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient

Scientific Title

Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient

Scientific Title:Acronym

Blood sugar and ketone body concentration at the time of the general anesthesia introduction of the cleft lip patient

Region

Japan


Condition

Condition

Healthy babies

Classification by specialty

Anesthesiology Oral surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the blood sugar and ketone body concentration at the time of the general anethesia introduction of the cleft lip babies.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

blood sugar
ketone body concentration

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Measurement of blood sugar at the time of the general anesthesia introduction.

Interventions/Control_2

Measurment of keton body concentration at the time of the general anesthesia introduction.

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

3 months-old <=

Age-upper limit

24 months-old >=

Gender

Male and Female

Key inclusion criteria

Healthy babies

Key exclusion criteria

Bad condition babies

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Jun
Middle name
Last name Harad

Organization

Aichi Gakuin University School of Dentistry

Division name

Department of Anesthesiology

Zip code

464-8651

Address

2-11 suemori-dori,Chikusa-ku,Nagoya,Aichi,Japan

TEL

052-759-2111

Email

nao.1020@hotmail.co.jp


Public contact

Name of contact person

1st name Naoko
Middle name
Last name Tachi

Organization

Aichi Gakuin University School of Dentistry

Division name

Department of Anesthesiology

Zip code

464-8651

Address

2-11 suemori-dori,Chikusa-ku,Nagoya,Aichi,Japan

TEL

052-759-2111

Homepage URL


Email

nao.1020@hotmail.co.jp


Sponsor or person

Institute

Aichigakuin Unversity,School of dentistry

Institute

Department

Personal name



Funding Source

Organization

Aichigakuin Unversity,School of dentistry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Aichigakuin Unversity,School of dentistry

Address

2-11 suemori-dori,Chikusa-ku,Nagoya,Aichi,Japan

Tel

052-759-2111

Email

nao.1020@hotmail.co.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

愛知学院大学歯学部付属病院(愛知県)


Other administrative information

Date of disclosure of the study information

2017 Year 05 Month 19 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

Completed

Date of protocol fixation

2016 Year 10 Month 07 Day

Date of IRB

2016 Year 11 Month 10 Day

Anticipated trial start date

2016 Year 11 Month 10 Day

Last follow-up date

2020 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 05 Month 19 Day

Last modified on

2020 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031407


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name