drugset / Trial / NCT05003570

Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in ICU

NCT05003570

Phase 3 Unknown 138 enrolled Southeast University, China
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Remifentanil has been approved by the FDA for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. However, National Medical Products Administration(NMPA) did not approve this indication. Therefore, the purpose of this study is to confirm the efficacy and safety of remifentanil in the analgesic therapy of critical ill patients in China.

Timeline

Start
2021-06-10
Primary completion
2022-12-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 1 ug/kg
Subject Remifentanil Small molecule 6 ug/kg

Indications

No indication recorded.