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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013447
Receipt No. R000015697
Scientific Title Non-anesthesiologist administrated propofol (NAAP) during endoscopic mucosal resection (EMR) of colorectal polyps
Date of disclosure of the study information 2014/03/18
Last modified on 2020/05/04

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Basic information
Public title Non-anesthesiologist administrated propofol (NAAP) during endoscopic mucosal resection (EMR) of colorectal polyps
Acronym EMR under NAAP
Scientific Title Non-anesthesiologist administrated propofol (NAAP) during endoscopic mucosal resection (EMR) of colorectal polyps
Scientific Title:Acronym EMR under NAAP
Region
Japan

Condition
Condition Colorectal polyps
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the safety and efficacy of endoscopic mucosal resection of colorectal polyps under Non-anesthesiologist administrated propofol.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate the safety by hemodynamics monitoring, the patients satisfaction and VAS(Visual Analog Scale) using questionnaires.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patients who are going to treat colorectal polyps in our or clinical cooperated hospital.
2) The patients who can understand the study and approve the treatment.
Key exclusion criteria 1) Performance Status (PS) 3 or 4.
2) American Society of Anesthesiologists (ASA) class over 3.
3) The patients who cannot stop their anticoagulation therapy.
4) The patients who cannot take the therapy because of their complications.
5) The patients who want to take the therapy, or the patients who were inappropriate condition.
6) The patients who were impossible to take the therapy at the discretion of primary doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Tominaga
Organization Yuri Kumiai General Hospital
Division name Department of Gastroenterology
Zip code
Address 38 Kawaguchiyago, Yurihonjoshi, Akita
TEL 0184-27-1200
Email aerasnt@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Tominaga
Organization Tokyo medical university
Division name Department of Gastroenterology and Hepatology
Zip code
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Homepage URL
Email aerasnt@gmail.com

Sponsor
Institute Naoyuki Tominaga
Institute
Department

Funding Source
Organization Tokyo medical university
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 18 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 Terminated
Date of protocol fixation
2014 Year 03 Month 17 Day
Date of IRB
2014 Year 03 Month 17 Day
Anticipated trial start date
2014 Year 03 Month 17 Day
Last follow-up date
2016 Year 03 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients received a slow initial intravenous bolus of 0.5 mg/kg/10 s of propofol. An automatic infusion pump was used to maintain a continuous infusion of 2-5 mg/kg/h. Additional intravenous boluses of propofol were slowly administered until the patient was sedated, as determined by a Ramsay sedation score of 4-6.
Patients were evaluated an awakening degree with Ramsay score in 10 minutes later, 30 minutes later, 60 minutes later and 120 minutes later. In additionally, Patients were evaluated the satisfaction and the pain during the treat with questionnaire and VAS(Visual Analog Scale) .

Management information
Registered date
2014 Year 03 Month 18 Day
Last modified on
2020 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015697

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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