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To verify whether remifentanil is more beneficial to reduce the duration of mechanical ventilation, shorten the interval from SBT to extubation, reduce the incidence of adverse events, reduce the workload of nursing staff, reduce the dosage of sedatives and ICU hospitalization costs, shorten the length of ICU hospitalization, and reduce the short-term mortality.
Opioids are widely used for analgesia in the ICU, of which, fentanyl and remifentanil are the most commonly used. Compared with the two analgesics, fentanyl is relatively cheap, but it is metabolised by liver. Long-term infusion makes its half-life extended, and side effects increase significantly. Respiratory depression is the most serious side effect and may lead to re-intubation and even sudden death.
Remifentanil is a strong selective μ-opioid receptor agonist, rapidly metabolized by non-specific plasma and tissue esterases into inactive metabolites; it has very short context-sensitive half-life even after prolonged infusion or in patients with organ failure. Remifentanil is easy to titrate and provides excellent analgesia: it allows higher doses administration than are normally used with traditional opioids without concerns about accumulation or delayed recovery.
This feature is helpful for patients with mechanical ventilation to weaning and extubate early. Previous studies comparing the two drugs mainly focus on short-term postoperative application, and theoretically long-term use can better reflect the pharmacokinetic advantages of Remifentanil. So we designed this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remifentanil group | Experimental | After enrollment, remifentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed. |
|
| fentanil group | Active Comparator | After enrollment, fentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Before infusion, remifentanil is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min. |
| Measure | Description | Time Frame |
|---|---|---|
| duration of mechanical ventilation | from the time of enrollment to successful removal from the ventilator | the end point of time is successfully transferred out of ICU or death or 28 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of adverse events | delirium, severe hypotension, severe bradycardia, constipation, chills, nausea and vomiting, muscle rigidity, accidental extubation | 1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-Xin Zhou, MD | Contact | 861059978019 | zhoujx.cn@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian-Xin Zhou, MD | Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU, Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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single-blind
|
|
| Fentanyl | Drug | Before infusion, fentanyl is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min. |
|
|
| the interval from SBT(Spontaneous Breathing Trial) to extubation | tracheal intubation has been successfully removed after the first SBT | the end point of time is successfully transferred out of ICU or death or 28 days after enrollment |
| dosages and costs of analgesic and sedative drugs | The consumption and cost of analgesic and sedative drugs in experimental group and control group | 1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |