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NCT05641909
Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in Intensive Care Unit
Conditions: Analgesia
Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE3
Enrollment: 138
Sponsor: Southeast University, China
Location: China
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.
Eligibility Criteria
Inclusion Criteria:Intubated in the past 24 hours with invasive mechanical ventilationExpected to continue mechanical ventilation for more than 48 hoursInformed consent/assent was obtained from all patients or their representativesExclusion Criteria:Patients with a history of allergy to opioids, benzodiazepines, propofol, or alcohol/drug abuse were excluded from the studyPatients who are known or suspected to be allergic to the study drugPatients whose expected survival time is less than 48hPatients receiving deep sedation (RASS≥-4)Patients using neuromuscular blocking agentPatients who cannot be assessed by RASSPatients with myasthenia gravispatients with bronchial asthmapatients with abdominal compartment syndromePatients who need surgery or tracheotomy during the study drug treatment periodWomen during pregnancy and lactationPatients who have used short-acting non-steroidal anti-inflammatory drugs within 6 hoursPatients who have used long-acting non-steroidal anti-inflammatory drugs within 12 hoursPatients with a history of chronic pain for more than 3 months or who are receiving regular analgesia for more than 3 monthsPatients who have used monoamine oxidase inhibitors within two weeksPatients who participate in any clinical trials as subjects within 1 monthPatients with a history of drug abuse, drug abuse, alcohol abuse* and long-term use of psychotropic drugs within 2 years Alcoholism: Drinking more than 14 times/week (1 time=150ml wine or 360ml beer or 45ml spirits)
Source: ClinicalTrials.gov (NCT05641909). StuddyBuddy aggregates publicly available trial information.