A Phase 3 interventional study of Remifentanil and Fentanyl in Analgesia, sponsored by Southeast University, China. Status unknown at 17 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Southeast University, China · Phase 3, Interventional, and Treatment
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 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).
Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: Remifentanil
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).
Drug: Fentanyl
Dosage forms and strengths: 3 mL Vial/1 mg lyophilized powder. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
Also known as: Remifentanil Hydrochloride for Injection
Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
Also known as: Fentanyl Citrate Injection
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).
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
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\<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: From study drug administration to the time discharge ICU , up to 72 hours
The proportion of subjects discharging the ICU
The proportion of subjects who discharge ICU to the total subjects.
Time frame: From study drug administration to the time discharge ICU, up to 24 weeks
ICU mortality
The proportion of subjects who died during ICU admission to the total subjects.
Time frame: From study drug administration to the time discharge ICU, up to 24 weeks
Hospital mortality
The proportion of subjects who died during hospital admission to the total subjects.
Time frame: From study drug administration to the time discharge hospital, up to 24 weeks
Length of ICU stay
The number of days the subject stayed in the ICU
Time frame: From administration to discharge ICU, up to 24 weeks
Length of hospital stay
The number of days the subject stayed in the hospital
Time frame: From administration to discharge hospital, up to 24 weeks
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: HR\<40bpm for less than 1 minute or HR\<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: RR\<10 bpm or SpO2\<90%
Time frame: From study drug administration to actual extubation , up to 72 hours
Analysis of the cost-effectiveness between remifentanil and fentanyl
cost-effectiveness
Time frame: From study drug administration to actual extubation , up to 72 hours
Plan to share: No
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Southeast University, China