Tolerability of Remimazolam Versus Midazolam in EUS

NCT07600073 | Recruiting

• 1 other identifier: L2-510
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This study will observe and compare patient experience during outpatient diagnostic endoscopic ultrasound (EUS) when moderate sedation is provided with either remimazolam plus fentanyl or midazolam plus fentanyl, according to routine clinical practice. Both sedation approaches are currently used in standard care. The choice of sedative will be made by the treating physician as part of usual practice and not assigned by the study. The purpose of the study is to evaluate how patients tolerate the procedure with each sedation strategy, focusing on comfort, recovery, and overall procedural experience. After the procedure, participants will be asked to complete questionnaires about their experience at 1 hour and 24 hours after EUS. The study will also collect information on sedation effectiveness, operator satisfaction, recovery time, adverse events, and costs. This is a prospective observational single-center study involving adult outpatients undergoing diagnostic EUS. Information collected during routine care, including vital signs, recovery measures, and procedural data, will be analyzed to compare outcomes between the two sedation approaches.

Conditions

Sedation During GI Endoscopy

Keywords

Remimazolam; Midazolam; Endoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• Tolerability of sedation

  Evaluated using patient-reported scale for tolerability of endoscopic procedures (PRO-STEP scale). The scale consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and throat pain. All questions are scored on a Likert scale from 0 to 10. Thus, higher scores underly a worse procedural tolerability.

  Tolerability of sedation will be evaluated 1 hour and 24 hours after the end of the endoscopic procedure

Secondary Outcomes (2)

• operator's satisfaction

  Periprocedural: Immediately after the endoscopic procedure

• recovery time

  Perioperative/Periprocedural: up to 2 hours after the procedure

Study Arms (2)

Remimazolam

Patients undergoing EUS under sedation with remimazolam

Midazolam

Patients undergoing EUS under sedation with midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult outpatients undergoing diagnostic EUS

You may qualify if:

• Age \> 18 years
• Outpatients undergoing diagnostic EUS (upper GI or biliopancreatic)
• Informed consent obtained

You may not qualify if:

• Known allergy to study medications
• Recent upper respiratory infection or asthma attack
• History of sedative or opioid addiction
• Advanced oncologic disease with peritoneal metastases
• ASA score ≥ IV

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Lecco: lead

Study Sites (1)

Ospedale Alessandro Manzoni

Lecco, Lecco, 23900, Italy

RECRUITING

Related Publications (3)

• Dahiya DS, Kumar G, Parsa S, Gangwani MK, Ali H, Sohail AH, Alsakarneh S, Hayat U, Malik S, Shah YR, Pinnam BSM, Singh S, Mohamed I, Rao A, Chandan S, Al-Haddad M. Remimazolam for sedation in gastrointestinal endoscopy: A comprehensive review. World J Gastrointest Endosc. 2024 Jul 16;16(7):385-395. doi: 10.4253/wjge.v16.i7.385.

  PMID: 39072252 BACKGROUND

• Guo J, Qian Y, Zhang X, Han S, Shi Q, Xu J. Remimazolam tosilate compared with propofol for gastrointestinal endoscopy in elderly patients: a prospective, randomized and controlled study. BMC Anesthesiol. 2022 Jun 10;22(1):180. doi: 10.1186/s12871-022-01713-6.

  PMID: 35689208 BACKGROUND

• Forbes N, Chau M, Koury HF, Lethebe BC, Smith ZL, Wani S, Keswani RN, Elmunzer BJ, Anderson JT, Heitman SJ, Hilsden RJ. Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation. Gastrointest Endosc. 2021 Jul;94(1):103-110.e2. doi: 10.1016/j.gie.2020.12.038. Epub 2020 Dec 30.

  PMID: 33385464 BACKGROUND

Central Study Contacts

Tommaso Pessarelli, MD

CONTACT

+393925133075; t.pessarelli@asst-lecco.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)