drugset / Trial / NCT04710914

Comparison of Extubation Delay After Prolonged Sedation

NCT04710914

Phase 4 Terminated 1 enrolled University Hospital, Rouen
RandomizedParallel-groupSingle-blindTreatment

Summary

This monocentric, prospective, controlled, randomized, single-blind study will be conducted in surgical resuscitation at the Rouen University Hospital. The aim of our research project is to evaluate the extubation time after sedation with inhaled isoflurane compared to conventional intravenous sedation with midazolam, in patients who require prolonged sedation (3 to 28 days) in a context of septic shock. This population is particularly at risk of hypnotic accumulation due to the prolonged duration of use and the increased risk of developing renal or hepatic impairment in connection with septic shock. Based on data from the literature on shorter durations of up to 96 hours of sedation, the investigators expect a decrease in the time to extubation in patients sedated with isoflurane as well as a better quality of awakening with a decrease in resuscitation delirium. This shortened duration of mechanical ventilation could have beneficial effects on the morbidity associated with prolonged sedation and ventilation: reduction of pneumopathies acquired under mechanical ventilation, reduction of the length of stay in resuscitation and hospitalization.

Timeline

Start
2020-12-15
Primary completion
2020-12-26
Completion
2020-12-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoflurane Other / unclassified Inhaled
Comparator Midazolam Small molecule Intravenous