AnesthesiaPhase 3SERENENCT07269808
Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration
A Phase 3 study testing Remimazolam and Propofol in people with Anesthesia and Sedation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is a pragmatic, randomized controlled pilot trial comparing remimazolam with propofol for endoscopic procedures, designed to assess the feasibility and clinical outcomes associated with implementing a pragmatic randomized trial of sedation practices in the endoscopy setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Sedation, Endoscopy
- What is being tested?
- Remimazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to 27 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Aged 18 years of age or older
- Planned endoscopic procedure
- American Society of Anesthesiologists (ASA) Physical Status I to III
Who cannot join
- Planned tracheal intubation
- Procedure length anticipated to exceed 45 minutes
- Previously participated in the trial
- Pregnant (defined as a positive test using pre-procedural clinical testing performed as part of their routine care) or breastfeeding
- Allergy or hypersensitivity to one of the study medications
- Blind, deaf, or unable to communicate in English
- Co-enrollment in other interventional studies that, in the opinion of the site investigator and/or their delegate, might interfere with study participation, collection, or interpretation of the study data
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
Official title: Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
This study is a pragmatic, randomized controlled pilot trial comparing remimazolam with propofol for endoscopic procedures, designed to assess the feasibility and clinical outcomes associated with implementing a pragmatic randomized trial of sedation practices in the endoscopy setting.
- Conditions
- Anesthesia, Sedation, Endoscopy
- Being tested
- Remimazolam, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called Byfavo
Remimazolam will be administered at 0.20 mg/kg for procedural sedation. The maximum initial bolus is 15 mg, with additional 2.5 mg doses given as needed to maintain sedation. Intravenous fentanyl (25-100 mcg) may be used adjunctively per clinician judgement
PropofolDrug
Also called Diprivan
Propofol will be administered with an initial bolus of up to 1.5 mg/kg, followed by intermittent 10-40 mg boluses according to routine clinical practice. Intravenous fentanyl (25-100 mcg) may be used adjunctively per clinician judgement.
| Study group | Role | What they receive |
|---|---|---|
| Arm Title: Remimazolam Sedation | Experimental | Participants randomized to this arm will receive remimazolam 0.20 mg/kg for procedural sedation. The maximum initial bolus will be 15 mg, with additional doses administered in 2.5 mg increments as needed to maintain adequate sedation. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This dosing strategy reflects the institution's standard-of-care approach to remimazolam-based sedation. Receives: Drug: Remimazolam |
| Propofol Sedation | Active comparator | Participants randomized to this arm will receive propofol up to 1.5 mg/kg as the initial bolus, followed by intermittent boluses of 10-40 mg according to routine clinical practice. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This regimen reflects the institution's standard-of-care approach to propofol-based sedation. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Meeting Inclusion/Exclusion Criteria
Counts the number of patients screened who meet all prespecified inclusion and exclusion criteria for trial eligibility.
Measured: From initiation of screening through end of study enrollment period.
Number of Patients Consented
Total number of eligible patients who provide informed consent to participate in the study.
Measured: From initiation of recruitment through end of study enrollment period.
Number of Patients Receiving the Randomized Intervention Per Protocol
Number of consented participants who are successfully randomized and receive their assigned sedation intervention according to the study protocol without major deviations.
Measured: From randomization through completion of the endoscopic procedure.
Number of Completed Questionnaires
Total number of study-related questionnaires completed by participants at the designated assessment time points, used to evaluate feasibility and acceptability of study procedures.
Measured: At the end of the procedure and at the immediate post-procedure assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start3 Mar 2026
- Primary completion27 Jun 2026
- Study completion27 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital
- Investigators
- Oluwaseun Johnson-Akeju, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269808
- Sponsor's protocol ID
- 2025P002893
- Acronym
- SERENE
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)
- ClinicalTrials.gov ID
- NCT07269808
- Acronym / sponsor ID
- SERENE / 2025P002893
- Conditions
- Anesthesia, Sedation, Endoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 27 Jun 2026 (actual)
- Study completion
- 27 Jun 2026 (actual)
- First posted
- 8 Dec 2025 (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.
This study is a pragmatic, randomized controlled pilot trial comparing remimazolam with propofol for endoscopic procedures, designed to assess the feasibility and clinical outcomes associated with implementing a pragmatic randomized trial of sedation practices in the endoscopy setting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Title: Remimazolam Sedation | Experimental | Drug: RemimazolamParticipants randomized to this arm will receive remimazolam 0.20 mg/kg for procedural sedation. The maximum initial bolus will be 15 mg, with additional doses administered in 2.5 mg increments as needed to maintain adequate sedation. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This dosing strategy reflects the institution's standard-of-care approach to remimazolam-based sedation. |
| Propofol Sedation | Active comparator | Drug: PropofolParticipants randomized to this arm will receive propofol up to 1.5 mg/kg as the initial bolus, followed by intermittent boluses of 10-40 mg according to routine clinical practice. Intravenous fentanyl (25-100 mcg) may be administered as an adjunct per clinician judgement. This regimen reflects the institution's standard-of-care approach to propofol-based sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years of age or older
- Planned endoscopic procedure
- American Society of Anesthesiologists (ASA) Physical Status I to III
Key exclusion criteria (7 listed)
- Planned tracheal intubation
- Procedure length anticipated to exceed 45 minutes
- Previously participated in the trial
- Pregnant (defined as a positive test using pre-procedural clinical testing performed as part of their routine care) or breastfeeding
- Allergy or hypersensitivity to one of the study medications
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: ByfavoRemimazolam will be administered at 0.20 mg/kg for procedural sedation. The maximum initial bolus is 15 mg, with additional 2.5 mg doses given as needed to maintain sedation. Intravenous fentanyl (25-100 mcg) may be used adjunctively per clinician judgement | Drug | Arm Title: Remimazolam Sedation |
| PropofolAlso: DiprivanPropofol will be administered with an initial bolus of up to 1.5 mg/kg, followed by intermittent 10-40 mg boluses according to routine clinical practice. Intravenous fentanyl (25-100 mcg) may be used adjunctively per clinician judgement. | Drug | Propofol Sedation |
Primary outcome
Number of Patients Meeting Inclusion/Exclusion Criteria
Time frame: From initiation of screening through end of study enrollment period.
Counts the number of patients screened who meet all prespecified inclusion and exclusion criteria for trial eligibility.
Number of Patients Consented
Time frame: From initiation of recruitment through end of study enrollment period.
Total number of eligible patients who provide informed consent to participate in the study.
Number of Patients Receiving the Randomized Intervention Per Protocol
Time frame: From randomization through completion of the endoscopic procedure.
Number of consented participants who are successfully randomized and receive their assigned sedation intervention according to the study protocol without major deviations.
Number of Completed Questionnaires
Time frame: At the end of the procedure and at the immediate post-procedure assessment.
Total number of study-related questionnaires completed by participants at the designated assessment time points, used to evaluate feasibility and acceptability of study procedures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Oluwaseun Johnson-Akeju, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remimazolam and Propofol in people with Anesthesia and Sedation, run by Massachusetts General Hospital at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Meeting Inclusion/Exclusion Criteria (time frame: From initiation of screening through end of study enrollment period.). The study lists 4 primary outcomes in all. 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 14 Sep 2026.