UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000015697