Remimazolam versus Midazolam for sedation during upper GI endoscopy: a randomized controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Antonius Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

21 Oct 2024 → ongoing

Decision date (initial)

2024-09-05

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the duration required for complete patient recovery following the administration of midazolam and remimazolam for procedural sedation during diagnostic upper GI endoscopies.

Secondary objectives 6

1. To evaluate the duration between arrival in the recovery room and complete patient recovery.
2. To evaluate duration required for patients to reach the readiness for discharge.
3. To evaluate the satisfaction of patients and endoscopists.
4. To evaluate duration of post-procedural amnesia.
5. To evaluate the procedural sedation success rates.
6. To evaluate adverse events.

Conditions and MedDRA coding

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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

Exclusion criteria 3

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.(16) Full alertness is defined as the first of 3 consecutive MOAA/S scores of at least 5.(16) The MOAA/S score is described in Appendix I.

Secondary endpoints 7

1. Time interval between patient arrival in the recovery room and full alertness.
2. Time to readiness for discharge, defined as the time interval from the last dosage of the sedative to readiness for discharge. Readiness for discharge is evaluated using the well-known and validated Aldrete score. This score is developed to measure when the patient recovery is sufficient for the patient to be discharged home. Readiness for discharge is defined as the first Aldrete score of at least 9.(17) The Aldrete score is described in Appendix II.
3. Patients satisfaction is scored using two different parts of a questionnaire modified from the patient satisfaction with sedation instrument (PSSI). The PSSI is a validated score of procedural sedation satisfaction for outpatient endoscopies.(18) The complete PSSI includes 20 multiple choice type questions which are categorised into 4 sub-scales for describing a patient’s satisfaction. In this study we focused on the PSSI sub-scores for global satisfaction and procedural recall in a modified PSS
4. Endoscopist satisfaction is scored by the endoscopist directly after the procedure (range 0-10, with 0 being the lowest score, and 10 the highest).
5. Post-sedation amnesia is scored using a self-developed amnesia test. The test is described in Appendix IV.
6. The success rate of sedation, defined as the percentage of procedures which will be finished as intended without requirement of > 5 boluses of midazolam and remimazolam, and without requirement for an alternative sedative.
7. Incidence of adverse events related to midazolam and remimazolam.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Antonius Ziekenhuis Stichting

Sponsor organisation

Sint Antonius Ziekenhuis Stichting

Address

Koekoekslaan 1

City

Nieuwegein

Postcode

3435CM

Country

Netherlands

Scientific contact point

Organisation

Sint Antonius Ziekenhuis Stichting

Contact name

Wetenschapsloket

Public contact point

Organisation

Sint Antonius Ziekenhuis Stichting

Contact name

Wetenschapsloket

Third parties 1

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications