In-hospital MortalityNCT06248346
Association Between Administration of Dexmedetomidine and Postoperative Mortality in Hospitals
An observational study of In-hospital Mortality, run by Xijing Hospital.
Trial summary
The present multicentre retrospective cohort study aimed to investigate the association between intraoperative administration of dexmedetomidine and postoperative mortality in hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-hospital Mortality
- What is being tested?
- Dexmedetomidine
- How many people
- 518,043 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All adult patients (aged ≥18 years) admitted for surgical procedures under general anaesthesia with propofol at the five participating hospitals from January 1, 2014 to June 30, 2018.
Who may be able to join
- adult patients (aged ≥18 years)
- undergo general anaesthesia with propofol
- from January 1, 2014 to June 30, 2018
Who cannot join
- patients undergoing intervention procedures under monitored anaesthesia care (MAC)
- patients undergoing minor procedures under local or regional anaesthesia
About this study
Official title: Association Between Administration of Dexmedetomidine and Postoperative Mortality in Hospitals Among Inpatients Undergoing Surgeries Under General Anaesthesia Using Propofol
The present multicentre retrospective cohort study aimed to investigate the association between intraoperative administration of dexmedetomidine and postoperative mortality in hospitals.
The investigators set out to test the hypothesis that perioperative dexmedetomidine use, as an adjunct to general anesthesia, diminishes postoperative mortality in hospitals across all categories of surgical patients.
- Conditions
- In-hospital Mortality
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
whether intraoperative dexmedetomidine was administered adjunct to propofol for patients undergoing surgeries under general anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | dexmedetomidine group: abbreviated for dexmedetomidine group, refers to the group with intraoperative administration of dexmedetomidine adjunct to propofol Receives: Drug: Dexmedetomidine | |
| non-dexmedetomidine | non-dexmedetomidine group: abbreviated for non-dexmedetomidine group, refers to the group without intraoperative administration of dexmedetomidine adjunct to propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital all-cause mortality
in-hospital deaths or discharged to hospice (or home)
Measured: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
Secondary outcomes (3)
length of postoperative hospital stay
in days
Measured: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
admission to the intensive care unit (ICU)
unplanned admissions
Measured: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
adverse events after surgery
severe stroke, the necessity for renal replacement therapy (RRT), myocardial infarction, ventilator-associated pneumonia (VAP), acute respiratory distress syndrome (ARDS), unplanned reoperation due to postoperative complications, sepsis, and multi-organ dysfunctions (MODs), if any
Measured: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Sep 2014
- Primary completion30 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-hospital MortalityStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Retrospective
- Enrolment
- 518,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, First Hospital of China Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Sir Run Run Shaw Hospital
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248346
- Sponsor's protocol ID
- KY20192045-C-1
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Administration of Dexmedetomidine and Postoperative Mortality in Hospitals Among Inpatients Undergoing Surgeries Under General Anaesthesia Using Propofol
- ClinicalTrials.gov ID
- NCT06248346
- Acronym / sponsor ID
- KY20192045-C-1
- Conditions
- In-hospital Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518,043 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, First Hospital of China Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Sir Run Run Shaw Hospital
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 8 Feb 2024 (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.
The present multicentre retrospective cohort study aimed to investigate the association between intraoperative administration of dexmedetomidine and postoperative mortality in hospitals.
The investigators set out to test the hypothesis that perioperative dexmedetomidine use, as an adjunct to general anesthesia, diminishes postoperative mortality in hospitals across all categories of surgical patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | – | Drug: Dexmedetomidinedexmedetomidine group: abbreviated for dexmedetomidine group, refers to the group with intraoperative administration of dexmedetomidine adjunct to propofol |
| non-dexmedetomidine | – | –non-dexmedetomidine group: abbreviated for non-dexmedetomidine group, refers to the group without intraoperative administration of dexmedetomidine adjunct to propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (aged ≥18 years) admitted for surgical procedures under general anaesthesia with propofol at the five participating hospitals from January 1, 2014 to June 30, 2018.
Key inclusion criteria (3 listed)
- adult patients (aged ≥18 years)
- undergo general anaesthesia with propofol
- from January 1, 2014 to June 30, 2018
Key exclusion criteria (2 listed)
- patients undergoing intervention procedures under monitored anaesthesia care (MAC)
- patients undergoing minor procedures under local or regional anaesthesia
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 |
|---|---|---|
| Dexmedetomidinewhether intraoperative dexmedetomidine was administered adjunct to propofol for patients undergoing surgeries under general anaesthesia | Drug | dexmedetomidine |
Primary outcome
in-hospital all-cause mortality
Time frame: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
in-hospital deaths or discharged to hospice (or home)
3 secondary outcomes
length of postoperative hospital stay
Time frame: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
admission to the intensive care unit (ICU)
Time frame: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
adverse events after surgery
Time frame: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No. IPD will not be available
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of In-hospital Mortality, run by Xijing Hospital.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
in-hospital all-cause mortality (time frame: from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 1 year). 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 8 Feb 2024.