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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033014
Receipt No. R000037629
Scientific Title Comparison sedation technique between Anesthesiologists and non-anesthesia providers in advanced gastrointestinal endoscopic procedures
Date of disclosure of the study information 2018/06/19
Last modified on 2018/06/15

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Basic information
Public title Comparison sedation technique between Anesthesiologists and non-anesthesia providers in advanced gastrointestinal endoscopic procedures
Acronym Comparison sedation technique between Anesthesiologists and non-anesthesia providers in advanced gastrointestinal endoscopic procedures
Scientific Title Comparison sedation technique between Anesthesiologists and non-anesthesia providers in advanced gastrointestinal endoscopic procedures
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuko Ikeda-Miyagawa
Organization Osaka City General Hospital
Division name Department of Anesthesiology and Intensive Care
Zip code
Address 2-13-22, Miyakojima-Hondori, Miyakojima, Osaka, Japan
TEL 06-69291221
Email yasuko.miyagawa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Ikeda-Miyagawa
Organization Osaka City General Hospital
Division name Department of Anesthesiology and Intensive care
Zip code
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)

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 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

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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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