A Comparative Study of the Sedative Effects and Safety of Anerem (Remimazolam) and Midazolam in Endoscopic Submucosal Dissection (ESD)

A Prospective Comparative Study of the Sedative Efficacy and Safety of Remimazolam (Anerem) versus Midazolam in Endoscopic Submucosal Dissection - ESD-REMIMID Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060378

Enrollment

100

Registered

2026-01-16

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal neoplasms indicated for Endoscopic Submucosal Dissection (ESD)

Interventions

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 perform

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Time to recovery from sedation (time from completion of ESD to full recovery of consciousness)	—

Secondary

Measure	Time frame
Time to induction of sedation (time from initiation of sedative administration to achievement of a Richmond Agitation-Sedation Scale (RASS) score of -2 to -3) Stability of sedation (assessed using RASS and bispectral index (BIS) monitoring) Completion rate of ESD (presence or absence of treatment interruption and successful resection) Incidence of adverse events (including oxygen desaturation, hypotension, respiratory depression, and bradycardia) Occurrence of paradoxical reactions Physician, nurse, and patient satisfaction (assessed using a 5-point Likert scale questionnaire)	—

Measure

Time frame

Time to induction of sedation (time from initiation of sedative administration to achievement of a Richmond Agitation-Sedation Scale (RASS) score of -2 to -3) Stability of sedation (assessed using RASS and bispectral index (BIS) monitoring) Completion rate of ESD (presence or absence of treatment interruption and successful resection) Incidence of adverse events (including oxygen desaturation, hypotension, respiratory depression, and bradycardia) Occurrence of paradoxical reactions Physician, nurse, and patient satisfaction (assessed using a 5-point Likert scale questionnaire)

—

Countries

Japan

Contacts

Public ContactAkira Tomioka

Saitama Medical College International Medical Center Department of Gastroenterology

a-tomioka@saitama-med.ac.jp+81-(42)-984-4111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026