UMIN-CTR Clinical Trial

Public title

A randomized clinical trial of Arginaid and Arginaid Water as preoperative oral rehydration for the pediatric patients undergoing elective surgery.

Acronym

Arginaid and Arginaid Water as preoperative oral rehydration for the pediatric patients.

Scientific Title

A randomized clinical trial of Arginaid and Arginaid Water as preoperative oral rehydration for the pediatric patients undergoing elective surgery.

Scientific Title:Acronym

Arginaid and Arginaid Water as preoperative oral rehydration for the pediatric patients.

Region

Japan

Condition

Pediatric patients undergoing elective surgery

Classification by specialty

Operative medicine

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of the preoperative oral rehydration (Arginaid and Arginaid Water) 2 hours prior to elective operations in pediatric patients.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Volume and pH of gastric content just after the induction of general anesthesia

Key secondary outcomes

Hunger and thirst before operations, Adverse events, Taste of the preoperative oral rehydrations

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Participated patients will be randomly divided into three groups. One is Arginaid Water group, another is Arginaid group the other is clear water group. Patients in Arginaid Wtare group intake Arginaid Water 10ml/kg (maximum 200ml) 2hours prior to the scheduled operation time.

Interventions/Control_2

Patients in Arginaid group intake Arginaid 10ml/kg (maximum 200ml) 2hours prior to the scheduled operation time.

Interventions/Control_3

Patients in Clear Water group intake clear water 10ml/kg (maximum 200ml) 2hours prior to the scheduled operation time.

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

15

years-old

>=

Gender

Male and Female

Key inclusion criteria

Pediatric patients who are scheduled to have elective operations.
American Society of Anesthesiologists physical status classification 1or2.
Pediatric patients who have submitted a written informed consent.

Key exclusion criteria

Obstruction of upper gastrointestinal tract, Ileus, dysphasia, Severe obesity (Body Mass Index>35), Increased intracranial pressure, recurrent nerve paralysis, Patients who are predicted to have difficulties in tracheal intubation, Patients who need pre-medications, A serum phosphorus>6mg/dL, Decision as ineligible by principal investigators.

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Miyamoto

Organization

Osaka University graduate school of medicine

Division name

Department of anesthesiology and intensive care

Zip code

Address

2-2, Yamadaoka, Suita, Osaka, 565-0871

TEL

+81-6-6879-3133

Email

miyamoto@anes.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoshikazu Miyamoto

Organization

Osaka University graduate school of medicine

Division name

Department of anesthesiology and intensive care

Zip code

Address

2-2, Yamadaoka, Suita, Osaka, 565-0871

TEL

+81-6-6879-3133

Homepage URL

http://www.med.osaka-u.ac.jp/pub/anes/www/home.htm

Email

miyamoto@anes.med.osaka-u.ac.jp

Institute

Osaka University graduate school of medicine

Institute

Department

Personal name

Organization

Osaka University graduate school of medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

13136

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院

Date of disclosure of the study information

2013

Year

11

Month

21

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

Open public recruiting

Date of protocol fixation

2013

Year

10

Month

29

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

29

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

11

Month

21

Day

Last modified on

2013

Year

11

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014467