Association Between Administration of Dexmedetomidine and Postoperative Mortality in Hospitals

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.

Study Overview

• Status: Completed
• Conditions: In-hospital Mortality
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Observational
• Enrollment (Actual): 518043

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
dexmedetomidine; dexmedetomidine group: abbreviated for dexmedetomidine group, refers to the group with intraoperative administration of dexmedetomidine adjunct to propofol	Drug: Dexmedetomidine; whether intraoperative dexmedetomidine was administered adjunct to propofol for patients undergoing surgeries under general anaesthesia
non-dexmedetomidine; non-dexmedetomidine group: abbreviated for non-dexmedetomidine group, refers to the group without intraoperative administration of dexmedetomidine adjunct to propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: The Affiliated Hospital of Qingdao University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Sir Run Run Shaw Hospital; First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: KY20192045-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No