UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison sedation technique between Anesthesiologists and non-anesthesia providers in advanced gastrointestinal endoscopic procedures
Title of the study (Brief title)	Comparison sedation technique between Anesthesiologists and non-anesthesia providers in advanced gastrointestinal endoscopic procedures
Region	Japan

Condition
Condition	cholelithiasis, cholecystitis, pancreatic cancer, gallbladder cancer, cholangiocarcinoma
Classification by specialty	Gastroenterology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The resulting of the increase the number of advanced gastrointestinal endoscopic procedures, Monitored Anesthesia Care:MAC has been in widespread use during the procedure. Due to the shortage of anesthesiologists, non anesthetic provider routinely administer sedatives. On this research, we compare the dose of sedatives, vital signs and the post operative sedation scale between anesthesiologists and non anesthetic providers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The continuous dose of oxygen, the dose of sedatives and pain killers, Vital signs during the procedure and after arriving the hospital room. Ramsay sedation score at operating room and after arriving at the hospital room.
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	110 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients taking endoscopic examination under sadation
Key exclusion criteria	None
Target sample size	500

Research contact person
Name of lead principal investigator	Yasuko Ikeda-Miyagawa
Organization	Osaka City General Hospital
Division name	Department of Anesthesiology and Intensive Care
Address	2-13-22, Miyakojima-Hondori, Miyakojima, Osaka, Japan
TEL	06-69291221
Email	yasuko.miyagawa@gmail.com

Public contact
Name of contact person	Yasuko Ikeda-Miyagawa
Organization	Osaka City General Hospital
Division name	Department of Anesthesiology and Intensive care
Address	2-13-22, Miyakojima-Hondori, Miyakojima, Osaka, Japan
TEL	06-69291221
Homepage URL
Email	yasuko.miyagawa@gmail.com

Sponsor
Institute	Osaka City General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	地方独立行政法人　大阪市民病院機構　大阪市立総合医療センター

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 19 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 15 Day
Anticipated trial start date	2018 Year 06 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Analyzing the dose of sedatives and examination time, Ramsay score between two groups using Student's T-test

Management information
Registered date	2018 Year 06 Month 15 Day
Last modified on	2018 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037629