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Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in ICU

NCT05003570 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2022-08-11

No results posted yet for this study

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.

Conditions

  • Analgesia

Interventions

DRUG

Remifentanil

Dosage forms and strengths: 3 mL Vial/1 mg lyophilized powder. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd

DRUG

Fentanyl

Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd

Sponsors & Collaborators

  • Southeast University, China

    lead OTHER

Principal Investigators

  • Yang Yi, MD · Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003570 on ClinicalTrials.gov