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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Remifentanil
Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
Anhui Provincial People's Hospital
Hefei, Anhui, China
RECRUITINGanalgesia 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).
Time frame: From study drug administration to actual extubation , up to 72 hours
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).
Time frame: 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
Time frame: 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.
Time frame: From study drug administration to actual extubation , up to 72 hours
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGQingyuan People's Hospital
Qingyuan, Guangdong, China
RECRUITINGAffiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGAffiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGFirst Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGEnshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi, Hubei, China
RECRUITING...and 8 more locations
The dosage of the remedial sedative drug propofol
Use the total dose of propofol
Time frame: 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.
Time frame: From study drug administration to wearing from mechanical ventilation, up to 72 hours
Extubation time
The start of the extubation process until actual extubation
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 month
ICU mortality
The proportion of subjects who died during ICU admission to the total subjects.
Time frame: Through study completion, an average of 1 month
Hospital mortality
The proportion of subjects who died during hospital admission to the total subjects.
Time frame: Through study completion, an average of 1 month
Length of ICU stay
The number of days the subject stayed in the ICU.
Time frame: Through study completion, an average of 1 month
Length of hospital stay
The number of days the subject stayed in the hospital.
Time frame: 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.
Time frame: 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.
Time frame: 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%
Time frame: 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
Time frame: From study drug administration to actual extubation , up to 72 hours