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CompletedNCT03975751Updated Jun 5, 2019

Practice of Sedation and Analgesia in Patients With Severe Brain Injury in China

An observational study in Intensive Care Unit, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-05.

Sponsored by Capital Medical University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
387
Ages
18 Years and older
Sex
All
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Study summary

Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies.

Read the detailed description

Sedation and analgesia is necessary management for patients in the intensive care units. The high-level studies of sedation and analgesia in China are still deficient, especially in patients with brain injuries who even have been excluded from the relevant studies. In the present study, a multicenter, 1-day point cross-sectional study about the sedation and analgesia among patients in China, particularly brain-injured will be investigated. The objectives are to investigate sedation and analgesia among patients in China and to compare sedation and analgesia between brain injuries and other patients.

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Conditions studied

  • Intensive Care Unit

Keywords

  • severe brain injuries
  • sedation and analgesia
  • intensive care unit
  • survey
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In context

Brain Injuries

2,125 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 387 is above the median of 100 across 692 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Capital Medical University is the lead sponsor of 293 studies on the registry; 91 are open to participants now.

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

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Who can participate

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

Study population

All the patients at 9am on the on-site investigation day in the participating ICUs will be screened and enrolled according to the inclusion and exclusion criteria.

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

  • All adult patients admitted to the participating ICUs on the investigation day

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years
  • Less than 24 hours of ICU stay before screening
  • Taking part in other studies
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
387 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testThe Glasgow Coma Scale (GCS)

    Use the common GCS, RASS and self-reported pain assessment for evaluating consciousness, agitation/sedation and analgesia.

    Also known as: The Richmond Agitation-Sedation Scale (RASS), The self-reported pain assessment

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What researchers measure

Primary outcomes

  1. Performance of sedation assessment

    The percentage of patients receiving sedation assessment

    Time frame: The previous 24 hours prior to the on-site investigation

  2. Performance of pain assessment

    The percentage of patients receiving pain assessment

    Time frame: The previous 24 hours prior to the on-site investigation

Secondary outcomes

  1. Use of sedatives

    The percentage of patients receiving sedatives

    Time frame: The previous 24 hours prior to the on-site investigation

  2. Use of analgesics

    The percentage of patients receiving analgesics

    Time frame: The previous 24 hours prior to the on-site investigation

  3. ICU mortality

    The percentage of patients dead in the ICU

    Time frame: Within 60 days after on-site investigation

  4. Hospital mortality

    The percentage of patients dead in the hospital

    Time frame: Within 60 days after on-site investigation

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Study locations

1 site
  • ICU, Beijing Tiantan Hospital, Capital Medical University
    Beijing, Beijing Municipality 100050, China
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References and documents

Publications

  • Chen K, Yang YL, Li HL, Xiao D, Wang Y, Zhang L, Zhou JX. A gap existed between physicians' perceptions and performance of pain, agitation-sedation and delirium assessments in Chinese intensive care units. BMC Anesthesiol. 2021 Feb 25;21(1):61. doi: 10.1186/s12871-021-01286-w. PubMed 33627067 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03975751
Responsible party
Jian-Xin Zhou (Professor, Capital Medical University) — Principal investigator
First posted
Jun 5, 2019
Start date
Jan 8, 2019
Primary completion
Jan 8, 2019
Completion
Mar 9, 2019
Last update
Jun 5, 2019

Study contacts

Jian-Xin Zhou, MD
study chair · Beijing Tiantan Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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