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| Name | Class |
|---|---|
| Yichang Humanwell Pharmaceutical Co., Ltd., China | INDUSTRY |
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The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lower loading dose of Nalbuphine hydrochloride for step 1 | Experimental | Nalbuphine hydrochloride injection, a loading dose of 4 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) |
|
| higher loading dose of Nalbuphine hydrochloride for step 1 | Experimental | Nalbuphine hydrochloride injection, a loading dose of 6 mg administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) |
|
| Hydromorphone hydrochloride injection for step 1 | Active Comparator | Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) |
|
| The optimal loading of Nalbuphine hydrochloride injection for step 2 | Experimental | Nalbuphine hydrochloride injection: a loading dose determined after step 1 administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) |
|
| Hydromorphone hydrochloride injection for step 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine hydrochloride injection | Drug | a loading dose of Nalbuphine hydrochloride injection administered in 30 ±10 seconds, followed by a maintenance dose of 2.0mg/h (a recommended maintenance dose range of 1.0~5.0mg/h) |
| Measure | Description | Time Frame |
|---|---|---|
| The analgesic success rate | The analgesic success is determined as 1) no use of rescue analgesic medication and 2) at least 70% of the time with CPOT ≤ 2 points | Within 24 hours while receiving the study drug |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of time with light sedation duration | Light sedation duration is defined as subjects with CPOT ≤ 2 points and -2 points ≤ RASS ≤ 1 | Within 24 hours while receiving the study drug |
| The amout of propfol used |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | peak plasma concentration | Within 24 hours while receiving the study drug |
| The area under the plasma drug concentration-time curve | The area under the plasma drug concentration-time curve (AUC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| you shang | Contact | 02785351606 | you_shanghust@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42131816 | Derived | Zhang Y, Yuan Y, Ren L, Jiang W, Sun S, Wang R, Li Z, Peng Q, Gong R, Yang X, Shang Y. Protocol for a multicenter, randomized, single-blind, non-inferiority trial comparing nalbuphine hydrochloride versus hydromorphone hydrochloride for analgesia in mechanically ventilated ICU patients. Front Pharmacol. 2026 Apr 28;17:1795531. doi: 10.3389/fphar.2026.1795531. eCollection 2026. |
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Hydromorphone hydrochloride injection: a maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) |
|
| Hydromorphone hydrochloride injection | Drug | A maintenance dose of 0.5mg/h (a recommended maintenance dose range of 0.5~3.0mg/h) |
|
The amout of propfol used
| Within 24 hours while receiving the study drug |
| Successful extubation | Successful extubated without reintubation | Within 24 hours while receiving the study drug |
| Within 24 hours while receiving the study drug |
| t1/2 | half-life | Within 24 hours while receiving the study drug |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| 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 |
| D009022 | Morphine Derivatives |
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