Tokyo, Jan. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060378) titled 'A Comparative Study of the Sedative Effects and Safety of Anerem (Remimazolam) and Midazolam in Endoscopic Submucosal Dissection (ESD)' on Jan. 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Akria Tomioka, Department of Gastroenterology, Saitama Medical College International Medical Center

Condition: Condition - Gastrointestinal neoplasms indicated for Endoscopic Submucosal Dissection (ESD) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - In the field of gastrointestinal endoscopy, benzodiazepines are essential sedative agents for reducing patient discomfort and ensuring the safe performance of endoscopic procedures. In recent years, the short-acting benzodiazepine sedative Anerem (remimazolam) has been newly approved, and its indications in gastrointestinal endoscopic procedures have been expanding. However, previous clinical studies have mainly focused on short-duration diagnostic or therapeutic procedures, and the clinical usefulness of remimazolam in prolonged and invasive procedures such as endoscopic submucosal dissection (ESD) has not been sufficiently evaluated. In particular, data regarding the stability of sedation, rapidity of recovery, safety, and their association with patient characteristics remain limited. The aim of this study is to compare the clinical efficacy and safety of sedation with remimazolam and midazolam in patients undergoing ESD, and to elucidate the true pharmacological effects of these agents after adjusting for patient background factors, including alcohol consumption history, prior benzodiazepine use, and renal function. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In this study, patients undergoing endoscopic submucosal dissection (ESD) are assigned to one of the following two intervention groups for procedural sedation: Remimazolam group: Sedation is performed using remimazolam (Anerem). Sedative agents are administered according to institutional standard protocols, and dosing is adjusted to maintain an appropriate level of sedation during the procedure. Interventions/Control_2 - In this study, patients undergoing endoscopic submucosal dissection (ESD) are assigned to one of the following two intervention groups for procedural sedation: Midazolam group: Sedation is performed using midazolam. Sedative agents are administered according to institutional standard protocols, and dosing is adjusted to maintain an appropriate level of sedation during the procedure.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Age: 18 years or older 2. ASA Physical Status Classification: Class I or II 3. Patients scheduled to undergo endoscopic submucosal dissection (ESD) for early esophageal cancer, early gastric cancer, or colorectal neoplasms 4. Provision of written informed consent to participate in this study Key exclusion criteria - 1. Severe hepatic impairment (Child-Pugh class C) or severe renal failure (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2) 2. Pregnant or breastfeeding women 3. History of airway obstruction or severe respiratory disease 4. History of allergy or hypersensitivity to benzodiazepines 5. Regular use of other sedative agents, such as propofol Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 15 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069066

Disclaimer: Curated by HT Syndication.