UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013447 |
|---|---|
| Receipt number | 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 21:20:25 |
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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
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
aerasnt@gmail.com
Sponsor or person
Institute
Naoyuki Tominaga
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015697
