UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060951 |
|---|---|
| Receipt number | R000069573 |
| Scientific Title | Determination of the Clinical Equipotent Dose Ratio of Remimazolam to Propofol in Colonoscopy: The RECIPE-C Study (Remimazolam Equipotent Conversion Index to Propofol in Endoscopy-Colon) |
| Date of disclosure of the study information | 2026/03/17 |
| Last modified on | 2026/03/16 18:38:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Determination of the Clinical Equipotent Dose Ratio of Remimazolam to Propofol in Colonoscopy: The RECIPE-C Study (Remimazolam Equipotent Conversion Index to Propofol in Endoscopy-Colon)
Acronym
RECIPE-C Study
Scientific Title
Determination of the Clinical Equipotent Dose Ratio of Remimazolam to Propofol in Colonoscopy: The RECIPE-C Study (Remimazolam Equipotent Conversion Index to Propofol in Endoscopy-Colon)
Scientific Title:Acronym
RECIPE-C Study
Region
| Japan |
Condition
Condition
Patients undergoing colonoscopy (for screening or diagnostic purposes)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To calculate the clinical equipotent dose ratio of RMZ to PRO in the same patients under opioid-free conditions.
2. To verify whether RMZ alone enables colonoscopy completion equivalent to PRO alone.
3. To evaluate differences in safety and quality of recovery.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose weight ratio (weight-adjusted total dose)
For each patient, the ratio of weight-adjusted doses calculated using the following formula (median and correlation coefficient):
Dose Weight Ratio (mg/kg) = Total Dose (mg) / Weight (kg)
Comparison of RMZ and PRO to derive the RMZ-to-PRO conversion ratio.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 20 years or older with opt-out consent obtained
Underwent colonoscopy for screening or diagnostic purposes with RMZ as the sedative
Had a colonoscopy under PRO monotherapy (opioid-free) at our institution within the past 2 years, completed by a single operator with a single scope to cecal intubation
Procedures performed by an expert endoscopist (board-certified gastroenterologist with >=2,000 colonoscopy experience) in both prior and current examinations
Key exclusion criteria
Change in ASA PS classification between prior and current examinations
History of colorectal surgery (except appendectomy)
Emergency endoscopy
Cases where procedural difficulty, invasiveness, or examination time was judged significantly different between prior and current examinations (e.g., therapeutic endoscopy such as ESD/EMR, severe adhesions, strictures)
Cold snare polypectomy for <=4 lesions is NOT excluded
Pregnant or possibly pregnant
Currently receiving opioids (including tramadol)
Judged inappropriate by the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Shimizu |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
Department of Gastroenterology
Zip code
983-0824
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-252-1111
takeshi.shimizu@openhp.or.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Shimizu |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
Department of Gastroenterology
Zip code
983-0824
Address
Sendai City Medical Center Sendai Open Hospital
TEL
022-252-1111
Homepage URL
takeshi.shimizu@openhp.or.jp
Sponsor or person
Institute
Sendai City Medical Center Sendai Open Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Sendai City Medical Center Sendai Open Hospital
Address
5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi, Japan
Tel
022-252-1111
masayuki.mori@openhp.or.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
| 2026 | Year | 03 | Month | 17 | 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
| 2026 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069573
