NCT06248346

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518,043

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

January 1, 2024

Enrollment Period

3.8 years

First QC Date

January 24, 2024

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • in-hospital all-cause mortality

    in-hospital deaths or discharged to hospice (or home)

    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

    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)

    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

    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

Study Arms (2)

dexmedetomidine

dexmedetomidine group: abbreviated for dexmedetomidine group, refers to the group with intraoperative administration of dexmedetomidine adjunct to propofol

Drug: Dexmedetomidine

non-dexmedetomidine

non-dexmedetomidine group: abbreviated for non-dexmedetomidine group, refers to the group without intraoperative administration of dexmedetomidine adjunct to propofol

Interventions

whether intraoperative dexmedetomidine was administered adjunct to propofol for patients undergoing surgeries under general anaesthesia

dexmedetomidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • adult patients (aged ≥18 years)
  • undergo general anaesthesia with propofol
  • from January 1, 2014 to June 30, 2018

You may not qualify if:

  • patients undergoing intervention procedures under monitored anaesthesia care (MAC)
  • patients undergoing minor procedures under local or regional anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 8, 2024

Study Start

September 1, 2014

Primary Completion

June 30, 2018

Study Completion

July 1, 2018

Last Updated

February 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

IPD will not be available