Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy.

BACKGROUND: While the complexity of flexible bronchoscopy has increased, standard options for moderate sedation medications have not changed in three decades. There is a need to improve moderate sedation while maintaining safety. Remimazolam was developed to address shortcomings of current sedation strategies. METHODS: A prospective, double-blind, randomized, multicenter, parallel group trial was performed at 30 US sites. The efficacy and safety of remimazolam for sedation during flexible bronchoscopy were compared with placebo and open-label midazolam. RESULTS: The success rates were 80.6% in the remimazolam arm, 4.8% in the placebo arm (P < .0001), and 32.9% in the midazolam arm. Bronchoscopy was started sooner in the remimazolam arm (mean, 6.4 ± 5.82 min) compared with placebo (17.2 ± 4.15 min; P < .0001) and midazolam (16.3 ± 8.60 min). Time to full alertness after the end of bronchoscopy was significantly shorter in patients treated with remimazolam (median, 6.0 min; 95% CI, 5.2-7.1) compared with those treated with placebo (13.6 min; 95% CI, 8.1-24.0; P = .0001) and midazolam (12.0 min; 95% CI, 5.0-15.0). Remimazolam registered superior restoration of neuropsychiatric function compared with placebo and midazolam. Safety was comparable among all three arms, and 5.6% of the patients in the remimazolam group had serious treatment-emergent adverse events as compared with 6.8% in the placebo group. CONCLUSIONS: Remimazolam administered under the supervision of a pulmonologist was effective and safe for moderate sedation during flexible bronchoscopy. In an exploratory analysis, it demonstrated a shorter onset of action and faster neuropsychiatric recovery than midazolam.

Risk assessment for inpatient survival in the long-term acute care setting after prolonged critical illness.

OBJECTIVE: The past decade has witnessed growth in the long-term acute care (LTAC) hospital industry. There are no reliable risk assessment models that can adjust outcomes across such facilities with different criteria for admitting patients. Variation in reported outcomes makes it difficult to determine whether a patient, or group of patients, may benefit from such care. This study sought to determine the extent to which survival in the LTAC setting is associated with age, race, residual organ system failures (OSFs), or APACHE (acute physiology and chronic health evaluation) III scores at the time of admission to LTAC. DESIGN: Retrospective medical record review. SETTING: Four freestanding facilities of a LTAC hospital. PATIENTS: A sample of 300 hospital admissions weighted to represent the study hospital population. MEASUREMENTS: Inpatient survival modeled as a function of age, APACHE III score calculated within 72 h prior to LTAC admission, and residual OSFs present on admission to LTAC. RESULTS: Logistic regression analysis shows age and OSF were most predictive of inpatient survival (receiver operating characteristic curve area = 0.81). APACHE III score was not predictive of survival in the multivariate model. CONCLUSIONS: Survival in LTAC is primarily associated with age and OSFs, which should be used to adjust for patient populations among LTAC settings when comparing outcomes. Our model identifies a group of patients with the poorest likelihood of survival in the LTAC setting, and may be used to facilitate dialogue with patients and family in cases where continued aggressive care is least effective.