SHOSREB — Remimazolam vs Propofol for Short-Term Light ICU Sedation

1. Publication

• Title: Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB)
• Acronym: SHOSREB
• Year & Journal: Intensive Care Medicine, epublished March 31, 2026 (2026;52:1001-1011)
• Citation: Yang X, Pan J, Gong X, et al. Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB): a multicentre, randomized, single-blind, controlled trial. Intensive Care Med. 2026;52:1001-1011. doi:10.1007/s00134-026-08381-x

2. Context & Rationale

Background: Remimazolam besylate is an ultra-short-acting benzodiazepine with a favorable pharmacokinetic profile (rapid hepatic-esterase metabolism). Prior smaller studies suggested comparability to propofol for light-to-moderate ICU sedation, but a dedicated multicenter non-inferiority trial for short-term light sedation had not been conducted.

Research Question/Hypothesis: In mechanically ventilated ICU patients requiring light sedation (RASS −2 to +1), is remimazolam besylate non-inferior to propofol for achieving successful sedation?

Why This Matters: Propofol carries risks of hypotension and injection pain/PRIS (propofol-related infusion syndrome) with prolonged use; a non-inferior alternative with a potentially better hemodynamic profile would be a useful addition to the ICU sedation armamentarium.

3. Design & Methods

• Study Type: Multicenter, randomized, single-blind, non-inferiority trial
• Setting & Centers: Multiple centers (China, based on author affiliations); specific count not detailed in available trial text
• Population:
• Inclusion: Mechanically ventilated ICU patients requiring light sedation (RASS −2 to +1)
• Exclusions: Not detailed in available trial text
• Intervention: Remimazolam besylate continuous infusion
• Comparator: Propofol continuous infusion
• Randomization: 1:1, 164 patients (82 remimazolam, 82 propofol)
• Blinding: Single-blind
• Statistical Power & Follow-Up: Primary outcome: successful sedation, defined as no rescue sedative administered during the study drug infusion period while maintaining RASS −2 to +1 for ≥70% of total infusion time.

4. Key Results

164 patients randomized equally (82/82).

Note on data completeness: The exact primary-outcome success-rate percentages and safety/adverse-event comparisons (e.g., hypotension incidence) were not available in the accessible source text used for this summary. Broader remimazolam-vs-propofol literature (in other settings, e.g., cancer-patient ICU sedation, endoscopy) consistently shows remimazolam achieves comparable sedation success with a more favorable hemodynamic/safety profile (less hypotension, less injection pain), but readers should consult the primary Intensive Care Medicine publication directly for SHOSREB's own exact figures before drawing firm conclusions.

5. Internal Validity Assessment

• Randomization & Allocation: 1:1 randomization; specific concealment mechanics not detailed in available trial text.
• Protocol Adherence & Separation: Similar infusion durations between arms suggest comparable real-world dosing conditions; the substantially different mg/kg/h doses reflect known potency differences between the two agents rather than a validity concern.
• Blinding & Detection Bias: Single-blind design (likely patient or outcome-assessor blinded, given the different physical appearance/preparation of the two drugs may limit full blinding) — specific blinding target not detailed in available text.
• Missing Data & Sensitivity Analyses: Not detailed in available trial text.
• Overall Internal Validity Conclusion: Indeterminate-to-moderate given incomplete access to the primary numeric result; the non-inferiority design and multicenter conduct are methodological strengths, but this summary cannot fully assess internal validity without the exact effect-size/CI data.

6. External Validity Assessment

• Population Representativeness: Mechanically ventilated ICU patients requiring light sedation — a common, clinically relevant ICU population.
• Practice Context: Both agents require standard ICU infusion capability; remimazolam availability varies by region/regulatory approval status.
• Overall External Validity Conclusion: Moderate — relevant to any ICU with access to remimazolam besylate; regional drug-availability differences may limit immediate applicability outside markets where remimazolam is approved for ICU use.

7. Strengths & Limitations

Strengths:

• Multicenter, randomized, non-inferiority design appropriate for a "new agent vs established standard" comparison
• Addresses light (rather than only deep) sedation, a common and clinically relevant ICU sedation target
• Builds on and extends prior single-center/pilot remimazolam-vs-propofol comparisons

Limitations:

• Exact primary-outcome numeric results not accessible for this summary
• Single-blind (not double-blind) design
• Modest sample size (164 patients) for a non-inferiority design, which typically requires larger samples than superiority trials to rule out clinically important inferiority

8. Interpretation & Practice Impact

• Clinical Implications: If non-inferiority was demonstrated (as the qualitative framing of available sources suggests), remimazolam besylate represents a viable alternative to propofol for short-term light ICU sedation, potentially with hemodynamic advantages consistent with the broader remimazolam literature.
• Mechanistic Coherence: Remimazolam's organ-independent (esterase-based) metabolism is consistent with a favorable safety profile in critically ill patients with variable hepatic/renal function.
• Systems-Level Takeaway: Supports considering remimazolam as an ICU formulary option for light sedation, pending full review of the primary publication's exact effect sizes and safety data.

9. Controversies & Subsequent Evidence

• Editorial Commentary/Debates: Not detailed in available trial text.
• Guideline Integration: Remimazolam is an active area of ICU sedation research (multiple 2026 trials in this space, including cancer-patient and deep-sedation populations), reflecting growing interest in benzodiazepine alternatives to propofol; SHOSREB adds specifically to the light-sedation evidence base.

10. Summary & Executive Takeaway

Summary: SHOSREB randomized 164 mechanically ventilated ICU patients requiring light sedation to remimazolam besylate or propofol in a multicenter, single-blind, non-inferiority design. Infusion durations were similar between groups (10.5h vs 11.0h, P=0.534); exact primary successful-sedation rates were not available in accessible source text.

Overall Takeaway: SHOSREB adds a dedicated, appropriately-designed non-inferiority trial to the growing remimazolam-vs-propofol evidence base specifically for light ICU sedation — consistent with the broader literature suggesting comparable efficacy with a potentially better safety profile, though this handbook entry could not confirm SHOSREB's own exact effect sizes from accessible sources.

11. Bibliography

• Yang X, Fu S, Yu L, et al. Efficacy and safety of remimazolam besylate in patients receiving mechanical ventilation: a randomized phase IIa trial.
• Zhao C, Fan X, Li L, et al. Remimazolam versus propofol for postoperative ICU sedation in mechanically ventilated cancer patients: a noninferiority randomized clinical trial. Front Pharmacol. 2026;17:1784928.