A Prospective Multicenter Registry Study of Sedation and Analgesia in Critically Ill Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Not applicable- observational study: Not applicable- observational study

Study summary

Sedation and analgesia are essential components of comprehensive care for intensive care unit (ICU) patients, particularly those receiving invasive mechanical ventilation, undergoing invasive procedures, or experiencing pain, anxiety, agitation, and patient-ventilator asynchrony. Appropriate sedation and analgesia can alleviate pain and discomfort, improve tolerance of mechanical ventilation and other life-support therapies, and help maintain treatment safety.

In recent years, the paradigm of ICU sedation has gradually shifted from traditional deep sedation toward management strategies centered on analgesia-first, light sedation, and individualized sedation targets. Clinical practice emphasizes regular assessment of pain, depth of sedation, and delirium, with dynamic adjustment of sedation and analgesia regimens according to the patient's condition. The Richmond Agitation-Sedation Scale (RASS) has been widely used to assess sedation depth in the ICU, while the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is commonly used for delirium screening in critically ill patients.

However, in real-world clinical practice, sedation requirements vary considerably among patients, and the choice of sedative agents is still influenced by multiple factors, including patient age, underlying diseases, circulatory status, organ function, mechanical ventilation requirements, and physicians' prescribing habits. Currently commonly used sedatives include propofol, dexmedetomidine, and midazolam, as well as newer intravenous sedatives that have been gradually introduced into clinical practice in recent years, such as remimazolam and ciprofol. These agents may differ in sedative efficacy, hemodynamic stability, speed of emergence, delirium risk, and duration of mechanical ventilation; however, direct comparative evidence among them in real-world ICU patients remains limited.

Moreover, sedation management is not merely a matter of drug selection. Depth and duration of sedation, dose adjustment, rescue sedation, combination therapy, and analgesic exposure may all affect patients' neurological status and clinical outcomes. Excessive or prolonged sedation may lead to delayed emergence, prolonged mechanical ventilation, coma, and delirium, whereas inadequate sedation may increase the risks of agitation, patient-ventilator asynchrony, self-extubation, and unplanned device removal.

Therefore, it is necessary to establish a standardized, prospective clinical database for ICU sedation and analgesia that systematically records patient baseline characteristics, disease severity, use of sedative and analgesic agents, sedation depth, pain, delirium, organ support, and clinical outcomes, and to evaluate the effectiveness and safety of different sedation and analgesia strategies based on real-world clinical practice.

This study aims to establish a prospective, multicenter registry cohort of sedation and analgesia in critically ill patients. Without interfering with clinicians' therapeutic decisions, it will systematically evaluate the characteristics of ICU sedation and analgesia practice and their association with patient clinical outcomes, and provide a high-quality data foundation for subsequent comparative effectiveness research on different sedative agents and sedation strategies, target trial emulation (TTE), and individualized sedation strategy research.

Eligibility

Primary outcome measure(s)

• Proportion of time within the target sedation range — Within 72 hours after initiation of the study sedation strategy
  Defined as the proportion of evaluable time during the first 72 hours in which the patient's actual RASS score falls within the target RASS range preset by the attending physician.
• Incidence of new-onset delirium at 7 days — Within 7 days after study enrollment
  Defined as at least one positive CAM-ICU assessment within 7 days after enrollment, assessed when the patient is non-comatose and able to complete the CAM-ICU evaluation.

Trial sites (1)

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