Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy: a Randomized Controlled Trial

NCT06614036 | Recruiting Phase 4

• 2 other identifiers: REST-study2024-516432-94-00
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 3

Brief Summary

Rationale Midazolam is known for its safety, effectiveness for procedural sedation during gastrointestinal (GI) endoscopy and is used as standard sedative by endoscopists worldwide. Remimazolam is a novel, recently approved sedative, with the potential to facilitate a faster (neuropsychiatric) recovery. Therefore, it may potentially enable earlier discharge and improvement of post-procedural memory compared to midazolam. Furthermore, remimazolam may enhance patient satisfaction. Objective The investigators aim to compare the use of remimazolam and midazolam for sedation during diagnostic upper GI endoscopies in a randomized clinical trial. Main trial endpoints Time to full alertness (time interval from the last dosage midazolam or remimazolam to the first of 3 consecutive MOAA/S scores of 5). Secondary trial endpoints Interval between arrival in the recovery room and full alertness, patient satisfaction (based on questionnaire after discharge and after 1 day), duration of amnesia (based on memory test after 1 day), time interval between last dosage of sedative and readiness for discharge (first Aldrete score of at least 9), total dosage and number of boluses for adequate sedation, time interval between first dosage of sedative and start of the procedure, endoscopist satisfaction (scored 0-10 after the procedure). Trial design Randomized, multicenter, double blind, clinical trial, which will take 2 days for study participants. Trial population Adult patients scheduled for diagnostic upper GI endoscopy with sedation. The anticipated use of fentanyl or other opioids during endoscopy is an exclusion criterium (n=148 patients). Interventions Participants will be randomly assigned to receive either remimazolam or midazolam as a sedative and will be followed up until one day after the procedure. One group will receive midazolam as a sedative, and another group will receive remimazolam as a sedative. Both agents will be administered in accordance with current guidelines. Vital signs, MOAA/S scores, and Aldrete scores will be monitored. Additionally, a memory test and a questionnaire will be administered to the participants. Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks This study aims to evaluate two procedures employed in regular daily care. Both sedatives used in this study are considered safe and effective for procedural sedation. Therefore, the investigators anticipate minimal risk for the participants involved in the study. Participants will not be subjected to any additional interventions or hospital visits apart from randomization, data collection, and two short questionnaires to evaluate amnesia and patient satisfaction. There will be no direct benefits for the participants as a result of their participation in this study.

Conditions

Sedation for Diagnostic Gastroscopy

Keywords

sedation; remimazolam; midazolam; gastroscopy; procedural sedation

Outcome Measures

Primary Outcomes (1)

• Time to full alertness

  Time to full alertness, defined as the time interval from the last dosage of the sedative and full alertness. Full alertness is evaluated using the well-known and validated MOAA/S score. This score is developed and validated to measure the level of alertness in subjects who are sedated. Full alertness is defined as the first of 3 consecutive MOAA/S scores of at least 5.

  From last dosage of the sedative until full alertness, assessed up to 60 minutes after last dosage

Secondary Outcomes (7)

• Patient satisfaction

  From first administration sedative until 1 day after diagnostic endoscopy

• Post-sedation amnesia

  From full alrtness until 1 day after diagnostic endoscopy

• Incidence adverse events

  From first dosage of sedative until one day after diagnostic gastroscopy

• Time interval between patient arrival in the recovery room and full alertness.

  From arrival recovery room until full alertness, assessed up to 90 minutes after arrival in the recovery room

• Endoscopist satisfaction

  From first dosage of sedative until end of endoscopic procedure, assessed up to 15 minutes after end of endoscopic procedure

Study Arms (2)

Remimazolam

EXPERIMENTAL

Byfavo 20 mg powder for solution for injection, remimazolam. Each vial contains remimazolam besylate equivalent to 20 mg remimazolam. Concentration after reconstitution: 2.5 mg/ml.

Drug: Remimazolam

Midazolam

ACTIVE COMPARATOR

Midazolam 1mg/ml, solution for injection / infusion. Each 5ml ampoule contains 5mg midazolam. Concentration: 1mg/ml.

Drug: Midazolam

Interventions

Remimazolam DRUG

Byfavo 20 mg powder for solution for injection, remimazolam. Each vial contains remimazolam besylate equivalent to 20 mg remimazolam. Concentration after reconstitution: 2.5 mg/ml.

Also known as: Midazolam

Remimazolam

Midazolam DRUG

Midazolam 1mg/ml, solution for injection / infusion. Each 5ml ampoule contains 5mg midazolam. Concentration: 1mg/ml.

Also known as: Remimazolam

Midazolam

Eligibility Criteria

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

You may qualify if:

• Patients age ≥ 18 years.
• Scheduled for a diagnostic upper GI endoscopy with procedural sedation.
• Ability to provide written informed consent, and to understand the responsibilities of trial participation.

You may not qualify if:

• Anticipated use of opioids, such as a therapeutic endoscopy or any other reason.
• ASA score of 4.
• Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent.

Sponsors & Collaborators

• Koen Munters: lead
• Gelre Hospitals: collaborator
• Rijnstate Hospital: collaborator

Study Sites (3)

Gelre Hospitals

Apeldoorn, Gelderland, 7334DZ, Netherlands

RECRUITING

Rijnstate hospital

Arnhem, Gelderland, 6815AD, Netherlands

RECRUITING

St Antonius hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

MeSH Terms

Interventions

remimazolam; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Koen Munters, MD

CONTACT

+31 088 755 07 21; k.munters@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr. B.L.A.M. Weusten

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: October 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

NL (3)