UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060835 |
|---|---|
| Receipt number | R000069574 |
| Scientific Title | Remimazolam Equipotent Conversion Index to Propofol in Endoscopy-Gastric: The RECIPE-G Study |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/05 16:20:18 |
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Basic information
Public title
A study comparing the required doses of two sedatives, Remimazolam and Propofol, in patients undergoing gastric endoscopy.
Acronym
RECIPE-G Study
Scientific Title
Remimazolam Equipotent Conversion Index to Propofol in Endoscopy-Gastric: The RECIPE-G Study
Scientific Title:Acronym
RECIPE-G
Region
| Japan |
Condition
Condition
Patients undergoing esophagogastroduodenoscopy (EGD) for screening or diagnostic purposes
Classification by specialty
| Gastroenterology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1: To calculate the clinical equipotent dose ratio of Remimazolam (RMZ) to Propofol (PRO) in the same patients under opioid-free conditions.
2: To verify whether RMZ alone enables completion of EGD equivalent to PRO alone.
3: To evaluate differences in safety and quality of recovery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Equipotent Dose Ratio calculated from the total dose per body weight (mg/kg) in cases that completed EGD while maintaining the target sedation depth (MOAA/S<=3) without concomitant use of other sedatives, analgesics, or flumazenil.
Key secondary outcomes
1: Dose-response model estimation: Estimation of ED50 (50% effective dose) and ED95 (95% effective dose) for RMZ and PRO
2: Recovery time: Rate of achieving Modified Aldrete score >=9 (discharge criteria) within 30 minutes of procedure completion
3: Safety: Incidence of respiratory depression, bradycardia, and disinhibition; rate of use of additional sedatives and reversal agents (flumazenil)
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 EGD for screening or diagnostic purposes with RMZ as the sedative.
Had an EGD under PRO monotherapy (opioid-free) at our institution within the past 2 years, completed without scope change.
Procedures performed by an expert endoscopist (board-certified gastroenterologist with >= 2,000 EGD experience), or a physician whose skill level is considered equivalent to an expert, in both prior and current examinations.
Key exclusion criteria
Patients with changes in ASA Physical Status (ASA PS) classification between the previous and current examinations.
Patients with differences in gastric anatomy due to surgical procedures between the previous and current examinations.
Patients with a history of surgical treatment of the esophagus, stomach, or duodenum.
Patients undergoing upper gastrointestinal endoscopic ultrasound (EUS).
Use of pharyngeal anesthesia in either the previous or current examination.
Patients undergoing emergency endoscopy.
Women who are pregnant or may be pregnant.
Patients receiving opioids (including tramadol).
Other patients judged unsuitable for the study by the attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Eto |
Organization
Public Interest Incorporated Foundation Sendai City Medical Center, Sendai, Japan.
Division name
Department of Gastroenterology.
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino Ward, Sendai City, Miyagi Prefecture, 983-0824, Japan
TEL
022-252-1111
etoy@openhp.or.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Eto |
Organization
Public Interest Incorporated Foundation Sendai City Medical Center, Sendai, Japan.
Division name
Department of Gastroenterology.
Zip code
983-0824
Address
5-22-1 Tsurugaya, Miyagino Ward, Sendai City, Miyagi Prefecture, 983-0824, Japan
TEL
022-252-1111
Homepage URL
etoy@openhp.or.jp
Sponsor or person
Institute
Public Interest Incorporated Foundation Sendai City Medical Center, Sendai, Japan.
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation Sendai City Medical Center, Sendai, Japan.
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
Institutional Review Board of Sendai City Medical Center, Sendai Open Hospital (Public Interest Incorporated Foundation)
Address
5-22-1 Tsurugaya, Miyagino Ward, Sendai City, Miyagi Prefecture, 983-0824, Japan
Tel
022-252-1111
dl_225ve@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 | 05 | 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 | 02 | 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 | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pre-treatment: Oral administration of 100 mL of water containing dimethylpolysiloxane (20 mg/mL, 1 mL) and a mixture of pronase and sodium bicarbonate (1 mL) 15-40 minutes before the procedure.
Content: Drugs are administered intravenously, with the sedation depth adjusted to a target MOAA/S score of 1-4.
RMZ Group (Current/Prospective): Remimazolam is administered intravenously. The procedure is initiated after confirming a MOAA/S score <= 3. Additional doses of 1-2 mg are administered in principle (while the total dose limit is generally set at 15 mg, further escalation is permitted) to maintain the target sedation depth. Rescue use of propofol, midazolam, or pentazocine is permitted for inadequate sedation. Flumazenil (0.25-0.5 mg) may be administered at the clinician's discretion if delayed emergence is predicted.
PRO Group (Historical Control): Data are extracted from the same patients' previous records where propofol was administered. In these cases, the procedure was initiated after confirming MOAA/S <= 3, and additional doses of 20 mg were administered in principle as needed according to the sedation status to maintain the target sedation depth.
Frequency: Once per upper gastrointestinal endoscopy session.
Duration: 1 day (only during the endoscopic procedure).
Management information
Registered date
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069574
