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Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydromorphone | Experimental | NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，maintenance dose 0.50mg/h |
|
| fentanyl | Active Comparator | NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，maintenance dose 0.08-0.2mg/h |
|
| Butorphanol | Active Comparator | NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，maintenance dose 0.7-10mg/kg/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone | Drug | Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump) |
|
| Measure | Description | Time Frame |
|---|---|---|
| successful analgesic proportion | Proportion of patients in each group who reached the target analgesia score range | From date of using the intervention drugs until the date of leaving from icu, up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Score | analgesia score, such as CPOT or NRS | From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days |
| dose of analgesics | total dose of analgesics during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongbin Hu, doctor | Contact | +8613922483752 | hobewoos@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern medical university Nanfang hospital | Recruiting | Guangzhou | 510515 | 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 |
|---|---|
| D004091 | Hydromorphone |
| D005283 | Fentanyl |
| D002077 | Butorphanol |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Fentanyl | Drug | Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump) |
|
| Butorphanol | Drug | Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump) |
|
| From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days |
| Adverse event | Adverse event during the study, including hypotension.et | From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days |
| ICU stay | duration of stay in ICU | from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |