SedationNCT07885930
A Prospective Multicenter Registry Study of Sedation and Analgesia in Critically Ill Patients
An observational study of Sedation and Analgesia Assessment, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation, Analgesia Assessment, ICU
- What is being tested?
- Not applicable- observational study
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2027to Dec 2029
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients admitted to the ICU who receive systemic sedation and/or analgesia during clinical treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Sedation, Analgesia Assessment, ICU
- Being tested
- Not applicable- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| Sedative agent group | Use of ciprofol, remimazolam, propofol, dexmedetomidine, midazolam, or other sedative agents. Receives: Other: Not applicable- observational study | |
| Analgesic agent group | Use of remifentanil, fentanyl, sufentanil, morphine, or other opioid or non-opioid analgesic agents. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours after initiation of the study sedation strategy
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.
Measured: Within 7 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885930
- Sponsor's protocol ID
- 2026ICUSedationAnalgesia
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Registry Study of Sedation and Analgesia in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07885930
- Acronym / sponsor ID
- 2026ICUSedationAnalgesia
- Conditions
- Sedation, Analgesia Assessment, ICU
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedative agent group | – | Other: Not applicable- observational studyUse of ciprofol, remimazolam, propofol, dexmedetomidine, midazolam, or other sedative agents. |
| Analgesic agent group | – | Other: Not applicable- observational studyUse of remifentanil, fentanyl, sufentanil, morphine, or other opioid or non-opioid analgesic agents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the ICU who receive systemic sedation and/or analgesia during clinical treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Analgesic agent group, Sedative agent group |
Primary outcome
Proportion of time within the target sedation range
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation and Analgesia Assessment, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of time within the target sedation range (time frame: Within 72 hours after initiation of the study sedation strategy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.