UMIN-CTR Clinical Trial

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

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013432
Receipt No. R000014603
Scientific Title Gastric fluid and pH 2 hours after intake of carbohydrate rich beverage (Arginaid Water) in patients with upper GI surgery, lower GI surgery and non-GI surgery
Date of disclosure of the study information 2014/04/01
Last modified on 2014/09/16

* 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 Gastric fluid and pH 2 hours after intake of carbohydrate rich beverage (Arginaid Water) in patients with upper GI surgery, lower GI surgery and non-GI surgery
Acronym Gastric volume and pH after intake of AW
Scientific Title Gastric fluid and pH 2 hours after intake of carbohydrate rich beverage (Arginaid Water) in patients with upper GI surgery, lower GI surgery and non-GI surgery
Scientific Title:Acronym Gastric volume and pH after intake of AW
Region
Japan

Condition
Condition Condition that would be treated with operation
Classification by specialty
Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The Enhanced Recovery After Surgery (ERAS) protocol recommends carbohydrate loading via oral administration before surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes gastric volume and pH
Key secondary outcomes nothing

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing elective surgery entering operating room at 8:30
Key exclusion criteria obstruction of gastrointestinal tract
heart surgery
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoi Sasuga
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of anesthesiology
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL 042-323-5111
Email motoi_sasuga@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoi Sasuga
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of anesthesiology
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan
TEL 042-323-5111
Homepage URL
Email motoi_sasuga@tmhp.jp

Sponsor
Institute Department of anesthesiology, Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Outside Japan
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 東京都立多摩総合医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 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
2011 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We placed a nasogastric or orogastric tube after induction of anesthesia and tracheal intubation. We aspirated gastric content into a 50-mL catheter syringe slowly for more than 5 minutes after tracheal intubation. We measured gastric volume and pH of the specimen using calibrated catheter syringe and a pH meter (waterproof pocket-sized pH meter, S2K712; Toyorika, Tokyo, Japan) respectively.

Management information
Registered date
2014 Year 03 Month 16 Day
Last modified on
2014 Year 09 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014603

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.