UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045023 |
|---|---|
| Receipt number | R000051103 |
| Scientific Title | Biomonitoring with BIS and capnography for appropriate sedation in endoscopic treatment |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2024/01/31 12:56:01 |
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Basic information
Public title
Biomonitoring with BIS and capnography for appropriate sedation in endoscopic treatment
Acronym
Biomonitoring for appropriate sedation in endoscopic treatment
Scientific Title
Biomonitoring with BIS and capnography for appropriate sedation in endoscopic treatment
Scientific Title:Acronym
Biomonitoring for appropriate sedation in endoscopic treatment
Region
| Japan |
Condition
Condition
Gastrointestinal epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of BIS monitor and capnography in management of sedation during endoscopic treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary goal is to address that respiratory depression and blood pressure fluctuations are smaller than the control group
Key secondary outcomes
(1) Amounts of drug used (diazepam, midazolam, dexmedetomidine hydrochloride)
(2) Changes in blood pressure, pulse, SpO2, respiratory rate, etCO2 during endoscopy
(3) Presence or absence of O2 administration
(4) Presence or absence of intraoperative and postoperative complications
(5) Ramsay scale and RASS during endoscopy
(6) Aldrete score and anesthesia recovery score leaving room
(7) Satisfaction (patients and doctors / nurses)
(8) Dosage of analgesic
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who schedule for endoscopic treatment of gastrointestinal epithelial tumors (esophageal high grade intraepithelial neoplasia, esophageal cancer, gastric adenoma, gastric cancer, duodenal adenoma, superficial duodenal cancer, colon adenoma, colon cancer).
Patients who undergo sedation in the endoscopy room during endoscopic treatment.
Patients who have received sufficient explanation before participating in this research, and who have obtained the informed consent of the research subject after sufficient understanding.
Key exclusion criteria
Patients who receive general anesthesia in the operating room.
Patients who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Endoscopy
Zip code
0608648
Address
Kita-ku N14 W5, Sapporo, Hokkaido, Japan
TEL
0117161161
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8638
Address
Kita-ku N15 W7, Sapporo, Hokkaido, Japan
TEL
0117161161
Homepage URL
cdf41180@par.odn.ne.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
W5, N14, Kita-ku, Sapporo, Hokkaido, Japan
Tel
0117067636
crjimu@huhp.hokidai.ac.jp
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
| 2021 | Year | 07 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate the following items and use the data for this research.
(1) Basic information of research subjects: age, gender, height, weight, diagnosis name, oral medication, medical history, drinking history, smoking history
(2) Biological monitor information: blood pressure, pulse rate, number / type of arrhythmia, percutaneous oxygen saturation (SpO2), respiratory rate, BIS value, expiratory terminal carbon dioxide (etCO2)
(3) Treatment information: lesion site, macroscopic diameter, treatment method, treatment time, drug used, drug amount used, drug administration time
(4) Sedation evaluation: Ramsay score, Richmond Agitation-Sedation Scale (RASS)
(5) Exit criteria: Aldrete score, anesthesia recovery score
(6) Post-implementation questionnaire: Satisfaction questionnaire by patients, satisfaction questionnaire by endoscopists, satisfaction questionnaire by nurses
(7) Presence or absence of complications: bleeding, perforation, thrombosis, postoperative delirium
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051103
