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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Meeting Inclusion/Exclusion Criteria | Counts the number of patients screened who meet all prespecified inclusion and exclusion criteria for trial eligibility. | 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. | 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. | 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. | At the end of the procedure and at the immediate post-procedure assessment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Duration of Adverse Clinical Events | Incidence and duration of predefined adverse clinical events, including respiratory insufficiency, hypoxemia, hypotension, and bradycardia, occurring during the procedure. | From induction of sedation through end of the procedure |
| Procedural Success |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oluwaseun Johnson-Akeju, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| 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. |
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Proportion of procedures completed successfully, defined as full completion of the planned endoscopic procedure with the patient maintaining adequate spontaneous ventilation throughout. |
| From induction of sedation through end of the procedure |
| Patient Satisfaction | Patient-reported satisfaction with the procedural sedation experience, assessed using a standardized post-procedure satisfaction questionnaire. | At the immediate post-procedure assessment |
| Provider Satisfaction | Satisfaction ratings from nurses, endoscopists, and anesthesiologists regarding the sedation process, collected using standardized provider questionnaire instruments. | Immediately after procedure completion |
| Procedure Duration | Total time from procedure start (scope insertion) to procedure end (scope removal), recorded in minutes. | From the start of the procedure through the end of the procedure |
| Post Anesthesia Care Unit Length of Stay | Time from the end of the endoscopic procedure to achievement of standardized post-anesthesia care unit discharge criteria. | Perioperative/Periprocedural |
| Time From Induction of Sedation to Procedure Start | Interval between administration of the initial sedation dose and the start of the endoscopic procedure (scope insertion). | From induction of sedation to procedure start |
| Richmond Agitation-Sedation Scale (RASS) Scores | Sedation depth assessed using repeated RASS measurements at prespecified intervals throughout the procedure. | Repeated measures assessed from induction of sedation through end of the procedure |
| Oxygen Saturation | Continuous or intermittent oxygen saturation (SpO₂) measurements collected at prespecified intervals during the procedure. | Repeated measures assessed from induction of sedation through end of the procedure |
| Blood Pressure Measurements | Repeated assessments of systolic, diastolic, and mean arterial blood pressure at prespecified intervals during the procedure. | Repeated measures assessed from induction of sedation through end of the procedure |
| Unplanned Conversion to General Anesthesia or Use of Non-Study Sedative | Number of cases requiring conversion to general anesthesia or administration of any sedative agent outside the assigned study drug protocol | From sedation induction through end of procedure. |
| Total Fentanyl Dose Administered | Cumulative dose of intravenous fentanyl administered as an adjunct to sedation during the procedure. | From induction of sedation to procedure end |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |