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Active, Not Recruiting

NCT Number: NCT07269808

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anesthesia Endoscopy Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years of age or older
  • Planned endoscopic procedure
  • American Society of Anesthesiologists (ASA) Physical Status I to III

Exclusion criteria

  • 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

Treatment and study plan

Remimazolam

Drug

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

Other names: Byfavo

Propofol

Drug

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.

Other names: Diprivan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. Incidence and Duration of Adverse Clinical Events

    Time frame: From induction of sedation through end of the procedure

    Incidence and duration of predefined adverse clinical events, including respiratory insufficiency, hypoxemia, hypotension, and bradycardia, occurring during the procedure.

  2. Procedural Success

    Time frame: From induction of sedation through end of the procedure

    Proportion of procedures completed successfully, defined as full completion of the planned endoscopic procedure with the patient maintaining adequate spontaneous ventilation throughout.

  3. Patient Satisfaction

    Time frame: At the immediate post-procedure assessment

    Patient-reported satisfaction with the procedural sedation experience, assessed using a standardized post-procedure satisfaction questionnaire.

  4. Provider Satisfaction

    Time frame: Immediately after procedure completion

    Satisfaction ratings from nurses, endoscopists, and anesthesiologists regarding the sedation process, collected using standardized provider questionnaire instruments.

  5. Procedure Duration

    Time frame: From the start of the procedure through the end of the procedure

    Total time from procedure start (scope insertion) to procedure end (scope removal), recorded in minutes.

  6. Post Anesthesia Care Unit Length of Stay

    Time frame: Perioperative/Periprocedural

    Time from the end of the endoscopic procedure to achievement of standardized post-anesthesia care unit discharge criteria.

  7. Time From Induction of Sedation to Procedure Start

    Time frame: From induction of sedation to procedure start

    Interval between administration of the initial sedation dose and the start of the endoscopic procedure (scope insertion).

  8. Richmond Agitation-Sedation Scale (RASS) Scores

    Time frame: Repeated measures assessed from induction of sedation through end of the procedure

    Sedation depth assessed using repeated RASS measurements at prespecified intervals throughout the procedure.

  9. Oxygen Saturation

    Time frame: Repeated measures assessed from induction of sedation through end of the procedure

    Continuous or intermittent oxygen saturation (SpO₂) measurements collected at prespecified intervals during the procedure.

  10. Blood Pressure Measurements

    Time frame: Repeated measures assessed from induction of sedation through end of the procedure

    Repeated assessments of systolic, diastolic, and mean arterial blood pressure at prespecified intervals during the procedure.

  11. Unplanned Conversion to General Anesthesia or Use of Non-Study Sedative

    Time frame: From sedation induction through end of procedure.

    Number of cases requiring conversion to general anesthesia or administration of any sedative agent outside the assigned study drug protocol

  12. Total Fentanyl Dose Administered

    Time frame: From induction of sedation to procedure end

    Cumulative dose of intravenous fentanyl administered as an adjunct to sedation during the procedure.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration (SERENE)

Acronym: SERENE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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