Association Between Administration of Dexmedetomidine and Postoperative Mortality in Hospitals

In-hospital Mortality Clinical Trial

Official title:

Association Between Administration of Dexmedetomidine and Postoperative Mortality in Hospitals Among Inpatients Undergoing Surgeries Under General Anaesthesia Using Propofol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06248346
• Other study ID #: KY20192045-C-1
• Status: Completed
• Start date: September 1, 2014
• Est. completion date: July 1, 2018

Study information

• Verified date: January 2024
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518043
• Est. completion date: July 1, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients (aged =18 years)

• undergo general anaesthesia with propofol

• from January 1, 2014 to June 30, 2018

Exclusion Criteria:

• patients undergoing intervention procedures under monitored anaesthesia care (MAC)

• patients undergoing minor procedures under local or regional anaesthesia

Related Conditions & MeSH terms

• In-hospital Mortality

Intervention

Drug:
• Dexmedetomidine
whether intraoperative dexmedetomidine was administered adjunct to propofol for patients undergoing surgeries under general anaesthesia

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Xijing Hospital	First Hospital of China Medical University, Sir Run Run Shaw Hospital, The Affiliated Hospital of Qingdao University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	length of postoperative hospital stay	in days	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	admission to the intensive care unit (ICU)	unplanned admissions	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	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	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