drugset / Trial / NCT03078946

Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery

NCT03078946 ↗

Phase 4 Completed 60 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindPrevention

Summary

This randomized double-blind parallel clinical study was conducted on 60 patients undergoing elective cardiac surgery under general anesthesia, at least 60 yr old, ASA I and II, 70-100 kg body weight and height 160-180 cm. Patients were randomized to: group A=30 patients receiving dexmedetomidine infusion (0.4- 0.7 µg /kg/h) or group B= 30 patients receiving morphine in a dose of 10-50μg/kg/hr as an analgesic with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg repeated as needed. Titration of the study medications infusions was conducted to maintain light sedation (RASS) (-2 to +1). Primary outcome was the prevalence of delirium measured daily via Confusion Assessment Method for intensive care. If Delirium and agitation occurred: haloperidol 2.5-5 mg IV was given in repeated boluses. Secondary outcomes included ventilation time, additional sedation/analgesia, hemodynamics and adverse effects.

Timeline

Start
2013-03
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.2 ug/kg —
Comparator Dexmedetomidine Other / unclassified 0.4 ug/kg —
Comparator Dexmedetomidine Other / unclassified 0.7 ug/kg —
Comparator Midazolam Small molecule 0.05 mg/kg —
Comparator Midazolam Small molecule 0.2 mg/kg —
Comparator Morphine Other / unclassified 10 ug/kg —
Comparator Morphine Other / unclassified 50 ug/kg —

Indications