Tokyo, March 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060951) titled '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)' on March 17.
Study Type:
Observational
Primary Sponsor:
Institute - Sendai City Medical Center Sendai Open Hospital
Condition:
Condition - Patients undergoing colonoscopy (for screening or diagnostic purposes)
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 20
years-old
=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 Size - 100
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069573
Disclaimer: Curated by HT Syndication.
