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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.
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 18 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Remifentanil |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| During the study drug administration period, the subjects are in the proportion of optimal time(CPOT score≤2) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonqiao Liu, MD | Contact | +86-25-83262552 | liusongqiao@ymail.com | |
| Liu Ling, MD | Contact | 13851435472 | liulingdoctor@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Yi, MD | Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial People's Hospital | Recruiting | Hefei | Anhui | 230000 | China |
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| Fentanyl | Drug | Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd |
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| From study drug administration to actual extubation , up to 72 hours |
| The number of times the remedial sedative drug propofol was used | Use the total times of propofol | From study drug administration to actual extubation , up to 72 hours |
| The proportion of subjects using the salvage sedative drug propofol | The proportion of subjects who using the salvage sedative drug propofol to the total subjects. | From study drug administration to actual extubation , up to 72 hours |
| The dosage of the remedial sedative drug propofol | Use the total dose of propofol | From study drug administration to actual extubation , up to 72 hours |
| Wearing time from mechanical ventilation | Wearing time criteria: The primary disease is improved, and there is no new disease; no use of vasopressors or continuous application of sedative drugs; cough reflex during sputum suction; PEEP≤5cmH2O; PaO2/FiO2≥200mmHg; Minute ventilation less than 15L/min; 2-minute spontaneous breathing test and passed. | From study drug administration to wearing from mechanical ventilation, up to 72 hours |
| Extubation time | The start of the extubation process until actual extubation | From the start of the extubation process until actual extubation , up to 72 hours |
| The success rate of wearing mechanical ventilator | The proportion of subjects who successfully wearing from mechanical ventilator to the total subjects. | From study drug administration to actual extubation , up to 72 hours |
| Duration of study drug use in ICU | The time from the start of the study drug administration to the time discharge ICU. | Through study completion, an average of 1 month |
| The proportion of subjects discharging the ICU | The proportion of subjects who discharge ICU to the total subjects. | Through study completion, an average of 1 month |
| ICU mortality | The proportion of subjects who died during ICU admission to the total subjects. | Through study completion, an average of 1 month |
| Hospital mortality | The proportion of subjects who died during hospital admission to the total subjects. | Through study completion, an average of 1 month |
| Length of ICU stay | The number of days the subject stayed in the ICU. | Through study completion, an average of 1 month |
| Length of hospital stay | The number of days the subject stayed in the hospital. | Through study completion, an average of 1 month |
| The incidence of study drug-related Lower blood pressure | Lower blood pressure: mean arterial pressure (MAP) drops more than 25% from the baseline level or requires additional vasopressors. | From study drug administration to actual extubation , up to 72 hours |
| The incidence of study drug-related slow heart rate | Slow heart rate: heart rate less than 40bpm for less than 1 minute or heart rate less than 60 bpm for more than 1 minute. | From study drug administration to actual extubation , up to 72 hours |
| The incidence of study drug-related respiratory depression | Respiratory depression: respiratory rate less than 10 bpm or oxygen saturation by pulse oximetry less than 90% | From study drug administration to actual extubation , up to 72 hours |
| Analysis of the cost-effectiveness between remifentanil and fentanyl | Analyze the best analgesic plan based on the results of the best analgesic effect | From study drug administration to actual extubation , up to 72 hours |
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 404100 | China |
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| Qingyuan People's Hospital | Recruiting | Qingyuan | Guangdong | 511500 | China |
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| Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550000 | China |
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| Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Enshi Tujia and Miao Autonomous Prefecture Central Hospital | Recruiting | Enshi | Hubei | 445000 | China |
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| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
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| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
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| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | 225000 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710000 | China |
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| Tianjin First Central Hospital | Recruiting | Tianjin | Tianjin Municipality | 30000 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Nanjing Zhong-Da Hospital, Southeast University | Recruiting | Nanjing | 210009 | China |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D007267 | Injections |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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