UMIN-CTR Clinical Trial

Public title

Standardization of Management during Pediatric Sedation for MRI
: A Prospective Observational Study

Acronym

Standardization of Management during Pediatric Sedation for MRI

Scientific Title

Standardization of Management during Pediatric Sedation for MRI
: A Prospective Observational Study

Scientific Title:Acronym

Standardization of Management during Pediatric Sedation for MRI

Region

Japan

Condition

Infants and children who need sedation for MRI

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We investigate the efficacy of our protocol, which includes well-designed sedation regimes using oral triclofos sodium or rectal chloral hydrate and intravenous midazolam offered with risk management plans. Thereby, we are going to establish standardized sedation regimes and risk management systems including monitoring during pediatric sedation for MRI

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

The rate of successful sedation, which defined the number of successful sedation cases divided by all cases.
Criteria of the successful sedation
Little of no motion artifacts on the images judged by radiologists.
Completion of MRI within the maximum dosage of the sedative protocol.

Key secondary outcomes

The rate of successful sedation during the length of normal MRI examination, which we set 40 minutes.
Adverse events during sedation.
Dosages of sedatives, time from the administration of sedatives until the completion of the adequate sedation, the time to return to the normal state of awareness.
The delay of the start of MRI from the scheduled time.
The rate of acceptable images, which defined the number of acceptable sequences divided by the number of all sequences.
Possible correlation between successful sedation and patient characteristics

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

0

years-old

<=

Age-upper limit

6

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients who require sedation for MRI judged by their doctors.
Informed written consent from the legal representatives for the participation of the study.

Key exclusion criteria

1 Class3 or 4 in ASA-Physical status
2 Class3 or 4 in Mallampaticlassification
3 Patients who have underlying disease with airway abnormality.
4 Patients with acute respiratory infection
5 Patients with known allergy to benzodiazepines or flumazenil
6 Patients on regular benzodiazepines
7 Previous participation of the study.
8 Patients who are assessed inappropriate for the study judged by the doctor in charge.

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Yukihiro Hasegawa

Organization

Tokyo Metropolitan Childrens' Medical Center

Division name

General Medicine

Zip code

Address

2-8-29,Musashidai,Fuchu-city,Tokyo Metropolice,183-8561,JAPAN

TEL

042-300-5111

Email

yukihiro_hasegawa@tmhp.jp

Name of contact person

1st name
Middle name
Last name	Takuto Takahashi

Organization

Tokyo Metropolitan Childrens' Medical Center

Division name

General Medicine

Zip code

Address

2-8-29,Musashidai,Fuchu-city,Tokyo Metropolice,183-8561,JAPAN

TEL

042-300-5111

Homepage URL

http://www.byouin.metro.tokyo.jp/shouni/tiken/index_rinshoukenkyu.html

Email

takuto_takahashi@tmhp.jp

Institute

Tokyo Metropolitan Childrens' Medical Center

Institute

Department

Personal name

Organization

Tokyo Metropolitan Childrens' Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都立小児総合医療センター(東京都)

Date of disclosure of the study information

2013

Year

08

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

26

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

02

Day

Last follow-up date

2014

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

None

Registered date

2013

Year

08

Month

13

Day

Last modified on

2015

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013436