Sedation for Diagnostic GastroscopyPhase 4RESTNCT06614036
Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy: a Randomized Controlled Trial
A Phase 4 study testing Remimazolam and Midazolam in people with Sedation for Diagnostic Gastroscopy, run by Koen Munters at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation for Diagnostic Gastroscopy
- What is being tested?
- Remimazolam and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesNetherlands
- Study dates
- 21 Oct 2024to 30 Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Gelre Hospitals
Apeldoorn, Gelderland, 7334DZ
Koen Munters, MD, +31 088 755 07 21, k.munters@antoniusziekenhuis.nl
Nicoline van Heel, MD, PhD
- Recruiting
Rijnstate hospital
Arnhem, Gelderland, 6815AD
Koen Munters, MD, +31 088 755 07 21, k.munters@antoniusziekenhuis.nl
Jordy Burger, MD, PhD
- Recruiting
St Antonius hospital
Nieuwegein, Utrecht, 3435CM
Koen Munters, MD, +31 088 755 07 21, k.munters@antoniusziekenhuis.nl
Bas Weusten, MD, PhD
About this study
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.
Read more
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
- Being tested
- Remimazolam, Midazolam
- Keywords
- sedation, remimazolam, midazolam, gastroscopy, procedural sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Midazolam
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.
MidazolamDrug
Also called Remimazolam
Midazolam 1mg/ml, solution for injection / infusion. Each 5ml ampoule contains 5mg midazolam. Concentration: 1mg/ml.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Remimazolam |
| Midazolam | Active comparator | Midazolam 1mg/ml, solution for injection / infusion. Each 5ml ampoule contains 5mg midazolam. Concentration: 1mg/ml. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From last dosage of the sedative until full alertness, assessed up to 60 minutes after last dosage
Secondary outcomes (7)
Patient satisfaction
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. The complete PSSI includes 19 multiple choice type questions which are categorised into 4 sub-scales for describing a patient's satisfaction. In this study the investigators focused on the PSSI sub-scores for global satisfaction and procedural recall in a modified PSSI.
Measured: From first administration sedative until 1 day after diagnostic endoscopy
Post-sedation amnesia
Post-sedation amnesia is scored using a self-developed amnesia test.
Measured: From full alrtness until 1 day after diagnostic endoscopy
Incidence adverse events
Incidence of adverse events related to midazolam and remimazolam.
Measured: From first dosage of sedative until one day after diagnostic gastroscopy
Time interval between patient arrival in the recovery room and full alertness.
Time interval between patient arrival in the recovery room and full alertness.
Measured: From arrival recovery room until full alertness, assessed up to 90 minutes after arrival in the recovery room
Endoscopist satisfaction
Endoscopist satisfaction is scored by the endoscopist directly after the procedure (range 0-10, with 0 being the lowest score, and 10 the highest).
Measured: From first dosage of sedative until end of endoscopic procedure, assessed up to 15 minutes after end of endoscopic procedure
Time to readiness for discharge
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.
Measured: From last dosage of sedative until readiness for discharge, assessed up to 90 minutes after last dosage
Succes rate of sedation
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.
Measured: From first dosage of sedative until end of endoscopic procedure, assesed up to 15 minutes after end of endoscopic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation for Diagnostic GastroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koen Munters
- Sponsor type
- University, hospital or other
- Collaborators
- Gelre Hospitals, Rijnstate Hospital
- Responsible party
- Sponsor-investigator, Koen Munters, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614036
- Sponsor's protocol ID
- REST-study
- Other IDs
- 2024-516432-94-00
- Acronym
- REST
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are currently discussing this topic
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam Versus Midazolam for Sedation During Upper GI Endoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06614036
- Acronym / sponsor ID
- REST / REST-study
- Conditions
- Sedation for Diagnostic Gastroscopy
- Keywords
- sedation, remimazolam, midazolam, gastroscopy, procedural sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Koen MuntersUniversity, hospital or other
- Collaborators
- Gelre Hospitals, Rijnstate Hospital
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: RemimazolamByfavo 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. |
| Midazolam | Active comparator | Drug: MidazolamMidazolam 1mg/ml, solution for injection / infusion. Each 5ml ampoule contains 5mg midazolam. Concentration: 1mg/ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamAlso: MidazolamByfavo 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 |
| MidazolamAlso: RemimazolamMidazolam 1mg/ml, solution for injection / infusion. Each 5ml ampoule contains 5mg midazolam. Concentration: 1mg/ml. | Drug | Midazolam |
Primary outcome
Time to full alertness
Time frame: From last dosage of the sedative until full alertness, assessed up to 60 minutes after last dosage
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.
7 secondary outcomes
Patient satisfaction
Time frame: From first administration sedative until 1 day after diagnostic endoscopy
Post-sedation amnesia
Time frame: From full alrtness until 1 day after diagnostic endoscopy
Incidence adverse events
Time frame: From first dosage of sedative until one day after diagnostic gastroscopy
Time interval between patient arrival in the recovery room and full alertness.
Time frame: From arrival recovery room until full alertness, assessed up to 90 minutes after arrival in the recovery room
Endoscopist satisfaction
Time frame: From first dosage of sedative until end of endoscopic procedure, assessed up to 15 minutes after end of endoscopic procedure
Time to readiness for discharge
Time frame: From last dosage of sedative until readiness for discharge, assessed up to 90 minutes after last dosage
Succes rate of sedation
Time frame: From first dosage of sedative until end of endoscopic procedure, assesed up to 15 minutes after end of endoscopic procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided. The investigators are currently discussing this topic
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam and Midazolam in people with Sedation for Diagnostic Gastroscopy, run by Koen Munters at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Koen Munters, MD (+31 088 755 07 21, k.munters@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to full alertness (time frame: From last dosage of the sedative until full alertness, assessed up to 60 minutes after last dosage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.