UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of gastric emptying of solid meal assessed by abdominal ultrasound
Title of the study (Brief title)	gastric emptying of solid meal assessed by abdominal ultrasound
Region	Japan

Condition
Condition	Adult patients scheduled for elective ophthalmologic surgery under local anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore gastric emptying time of solid meal
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cross sectional area of antrum measured by abdominal ultrasound
Key secondary outcomes

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients scheduled for elective opthalamologic surgery under local anesthesia 2) Patients who have morning meal and have afternoon surgery
Key exclusion criteria	1) Patients who can not abide fasting 2) Patients with stomach obstruction 3) Patients with oral ingestion impossible 4) Patients who have past history of aspiration pneumonia 5) Pregnant women 6) Patients with possible sedation 7) Patients can not cooperate ultrasound assessment
Target sample size	50

Research contact person
Name of lead principal investigator	Shiroh Isono
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Anesthesiology
Address	Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL	043222-7171
Email	shirohisono@yahoo.co.jp

Public contact
Name of contact person	Shiroh Isono
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Anesthesiology
Address	Inohana 1-8-1, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	shirohisono@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Scholarship donation
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 12 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a prospective Cohort study exploring gastric emptying time determined by residual gastric contents and fasting time in patients scheduled for elective opthalamologic surgery under local anesthesia. Patients is asked to fast solid meal after morning meal, but allows to drink clear fluid until 2 hours before operation. Immediately before the operation, abdominal ultrasound is performed to measure cross sectional area of antrum in the lateral position. Subgroup analyses are planned for patients with diabetes mellitus and for patients over 80 years old.

Management information
Registered date	2015 Year 12 Month 18 Day
Last modified on	2016 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023395