ClinicalTrials.gg
Enrolling by invitationNCT07885930Updated Oct 21, 2026

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

An observational study in Sedation, Analgesia Assessment and ICU, sponsored by Beijing Chao Yang Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Beijing Chao Yang Hospital · Observational

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Sedation
  • Analgesia Assessment
  • ICU
03

In context

Lead sponsor

Beijing Chao Yang Hospital is the lead sponsor of 139 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult critically ill patients admitted to the ICU who receive systemic sedation and/or analgesia during clinical treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years;
  • Admission to the ICU;
  • Receipt of intravenous or other systemic sedative and/or analgesic therapy during ICU stay;
  • Expected ICU length of stay ≥ 24 hours;
  • The patient or their legally authorized representative provides informed consent in accordance with ethical requirements.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years;
  • Expected death within 24 hours at screening;
  • Decision already made to withdraw or withhold life-sustaining treatment within 24 hours;
  • Admission to the ICU solely for routine postoperative observation without clinical need for sedation or analgesia;
  • Pregnant or breastfeeding women;
  • Already enrolled in this study during the same hospitalization;
  • The patient or their legally authorized representative declines participation in the study;
  • Other circumstances in which the investigator judges that the primary study variables cannot be reliably obtained or that the patient is otherwise unsuitable for enrollment in this study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • Sedative agent group

    Use of ciprofol, remimazolam, propofol, dexmedetomidine, midazolam, or other sedative agents.

    Other: Not applicable- observational study

  • Analgesic agent group

    Use of remifentanil, fentanyl, sufentanil, morphine, or other opioid or non-opioid analgesic agents.

    Other: Not applicable- observational study

Interventions

  • OtherNot applicable- observational study

    Not applicable- observational study

06

What researchers measure

Primary outcomes

  1. Proportion of time within the target sedation range

    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.

    Time frame: Within 72 hours after initiation of the study sedation strategy

  2. Incidence of new-onset delirium at 7 days

    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.

    Time frame: Within 7 days after study enrollment

07

Study locations

1 site
  • Beijing Chao Yang Hospital
    Beijing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Dec 2029, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2026
First posted
Oct 21, 2026
StartEst.
Jan 2027
Primary completionEst.
Dec 2029
CompletionEst.
Dec 2029
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07885930
Collaborators
Beijing Jishuitan Hospital
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Oct 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion