Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in Intensive Care Unit

NCT05641909 | Unknown Phase 3 DMC

• 1 other identifier: ZDRFF
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 18

Brief 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

Keywords

analgesia; analgesia based sedation; critical care; fentanyl; propofol; remifentanil; sedation

Outcome Measures

Primary Outcomes (1)

• analgesia success rate(the proportion of subjects with successful analgesia to the number of subjects in each group)

  Analgesia success is defined as: 1. No salvage analgesics were used during the administration of the study drug; 2 During the administration of the study drug, the time for the analgesia score of subjects to reach the standard (CPOT score ≤ 2) was greater than 70%. 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).

  From study drug administration to actual extubation , up to 72 hours

Secondary Outcomes (17)

• During the study drug administration period, the subjects are in the proportion of optimal time(CPOT score≤2)

  From study drug administration to actual extubation , up to 72 hours

• The number of times the remedial sedative drug propofol was used

  From study drug administration to actual extubation , up to 72 hours

• The proportion of subjects using the salvage sedative drug propofol

  From study drug administration to actual extubation , up to 72 hours

• The dosage of the remedial sedative drug propofol

  From study drug administration to actual extubation , up to 72 hours

• Wearing time from mechanical ventilation

  From study drug administration to wearing from mechanical ventilation, up to 72 hours

Study Arms (2)

Remifentanil

EXPERIMENTAL

Remifentanil analgesia combined with propofol sedation. Treatment was started in patients with an CPOT score of 2 or greater after completion of baseline assessments. All patients received an initial infusion of blinded opioid (placebo bolus dose(6ml) \+ 6ug/kg per hour infusion at 6 ml/hour). Optimal analgesia (CPOT score ≤2) was then targeted by titrating the infusion in 1.5 ml/hour increments (placebo bolus dose + 1.5ug/kg per hour rate increase). Only when the opioid infusion rate had reached the 'propofol trigger dose' (12ml/h; 12ug/ kg per hour) was propofol to be administered as an initial bolus dose of up to 0.5 mg/kg and an infusion of 0.5mg/kg per hour, and titrated in 25% increments (0.25mg/kg bolus dose + 0.125mg/kg per hour rate increase to treat agitation.

Drug: Remifentanil

Fentanyl

ACTIVE COMPARATOR

Fentanyl analgesia combined with propofol sedation. Treatment was started in patients with an CPOT score of 2 or greater after completion of baseline assessments. All patients received an initial infusion of blinded opioid (1ug/kg bolus(6ml) + 1ug/kg per hour infusion at 6ml/hour). Optimal analgesia (CPOT score ≤2) was then targeted by titrating the infusion in 1.5 ml/hour increments (1ug/kg bolus dose + 0.25ug/kg per hour rate increase). Only when the opioid infusion rate had reached the 'propofol trigger dose' (12ml/h; 2ug/kg per hour) was propofol to be administered as an initial bolus dose of up to 0.5 mg/kg and an infusion of 0.5mg/kg per hour, and titrated in 25% increments (0.25mg/kg bolus dose + 0.125mg/kg per hour rate increase to treat agitation.

Drug: Fentanyl

Interventions

Remifentanil DRUG

Remifentanil

Also known as: Remifentanil Hydrochloride for Injection

Remifentanil

Fentanyl DRUG

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

Also known as: Fentanyl Citrate Injection

Fentanyl

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intubated in the past 24 hours with invasive mechanical ventilation
• Expected to continue mechanical ventilation for more than 48 hours
• Informed consent/assent was obtained from all patients or their representatives

You may not qualify if:

• Patients with a history of allergy to opioids, benzodiazepines, propofol, or alcohol/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 6 hours
• Patients who have used long-acting non-steroidal anti-inflammatory drugs within 12 hours
• Patients with a history of chronic pain for more than 3 months or who are receiving regular analgesia for more than 3 months
• Patients who have used monoamine oxidase inhibitors within two weeks

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (18)

Anhui Provincial People's Hospital

Hefei, Anhui, 230000, China

RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 404100, China

RECRUITING

Qingyuan People's Hospital

Qingyuan, Guangdong, 511500, China

RECRUITING

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Enshi Tujia and Miao Autonomous Prefecture Central Hospital

Enshi, Hubei, 445000, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225000, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710000, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 30000, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Nanjing Zhong-Da Hospital, Southeast University

Nanjing, 210009, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Remifentanil; Injections; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yang Yi, MD

  Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

  STUDY CHAIR

Central Study Contacts

Sonqiao Liu, MD

CONTACT

+86-25-83262552; liusongqiao@ymail.com

Liu Ling, MD

CONTACT

13851435472; liulingdoctor@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: August 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)