Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in ICU

Last updated: August 9, 2022
Sponsor: Southeast University, China
Overall Status: Active - Recruiting

Phase

3

Condition

Pain

Treatment

N/A

Clinical Study ID

NCT05003570
ZDRF
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Invasive mechanical ventilation with endotracheal intubation
  • Expected to continue mechanical ventilation for more than 12 hours
  • Informed consent/assent was obtained from all patients or their representatives

Exclusion

Exclusion Criteria:

  • Patients with a history of allergy to opioids, benzodiazepines, propofol, oralcohol/drug abuse were excluded from the study
  • Patients who are known or suspected to be allergic to the study drug
  • Patients whose expected survival time is less than 48h
  • Patients receiving deep sedation (RASS≥-4)
  • Patients using neuromuscular blocking agent
  • Patients who cannot be assessed by RASS
  • Patients with myasthenia gravis
  • patients with bronchial asthma
  • patients with abdominal compartment syndrome
  • Patients who need surgery or tracheotomy during the study drug treatment period
  • Women during pregnancy and lactation
  • Patients who have used short-acting non-steroidal anti-inflammatory drugs within 6hours
  • Patients who have used long-acting non-steroidal anti-inflammatory drugs within 12hours
  • Patients with a history of chronic pain for more than 3 months or who are receivingregular analgesia for more than 3 months
  • Patients who have used monoamine oxidase inhibitors within two weeks
  • Patients who participate in any clinical trials as subjects within 1 month
  • Patients with a history of drug abuse, drug abuse, alcohol abuse* and long-term use ofpsychotropic drugs within 2 years Alcoholism: Drinking more than 14 times/week (1time=150ml wine or 360ml beer or 45ml spirits)

Study Design

Total Participants: 138
Study Start date:
June 10, 2021
Estimated Completion Date:
December 30, 2022

Study Description

The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 17 centres in China were recruited. All patients were randomized, in a double-blind manner, to receive either a remifentanil-propofol regimen or a fentanyl-propofol regimen for analgesia and sedation in the ICU. The aim of the study was to achieve optimal sedation and patient comfort by maintaining an optimal Critical Care Pain Observation Tool (CPOT) score of 2, without clinically significant pain, until the start of the extubation process or for 72 hours, whichever occurred first. CPOT scoring criteria: Facial expressions(Relaxed, neutral=0; Tense=1; Grimacing=2); Body movements(Absence of movements or normal position=0; Protection=1; Restlessness/Agitation=2); Muscle tension(Relaxed=0; Tense, rigid=1; Very tense or rigid=2); Compliance with the ventilator or Vocalization(Tolerating ventilator or movement/Talking in normal tone or no sound=0; Coughing but tolerating/Sighing, moaning=1; Fighting ventilator/Crying out, sobbing=2).

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 404100
    China

    Active - Recruiting

  • Qingyuan People's Hospital

    Qingyuan, Guangdong 511500
    China

    Active - Recruiting

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou 550000
    China

    Active - Recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou 563000
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Enshi Tujia and Miao Autonomous Prefecture Central Hospital

    Enshi, Hubei 445000
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Yichang Central People's Hospital

    Yichang, Hubei 443000
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Nanjing Zhong-Da Hospital, Southeast University

    Nanjing, Jiangsu 210009
    China

    Active - Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710000
    China

    Site Not Available

  • Tianjin First Central Hospital

    Tianjin, Tianjin 30000
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

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