drugset / Trial / NCT02119806

Decreasing the Incidence of Delirium After Cardiac Surgery

NCT02119806 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

In critically ill surgical patients, delirium (confusion and disorientation) is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. The goal of the study is to establish whether benzodiazepines (a sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by comparing the chances of delirium in cardiac surgery patients between two groups: a group that receives benzodiazepines during surgery versus a group that does not receive benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner preference. Findings of this study will allow all anesthesiologists to make more informed decisions about what level of care our patients need.

Timeline

Start
2017-08
Primary completion
2017-08
Completion
2017-08

Outcome

Outcome not reported

Stopped: “Study was never initiated.”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.02 mg/kg —
Comparator Midazolam Small molecule 0.1 mg/kg —
Comparator Fentanyl Other / unclassified 0 ug —
Comparator Fentanyl Other / unclassified 10 ug/kg —
Comparator Fentanyl Other / unclassified 30 ug/kg —
Comparator Fentanyl Other / unclassified 250 ug —
Comparator Propofol Small molecule 0 mg —
Comparator Propofol Small molecule 10 ug/kg —
Comparator Propofol Small molecule 100 ug/kg —
Comparator Propofol Small molecule 50 mg —

Indications