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The goal of this clinical trial is to learn if oxycodone hydrochloride works to manage pain in patients requiring mechanical ventilation. It will also assess the safety of oxycodone hydrochloride. The main questions it aims to answer are:
Participants will:
This study is a single-center, single-blind, randomized controlled exploratory study involving subjects aged 18 to 80 who are expected to require mechanical ventilation for ≥24 hours and who were intubated and received mechanical ventilation for less than 3 days before enrollment. Subjects will be treated with either oxycodone hydrochloride injection or remifentanil injection and will be randomly assigned in a 1:1 ratio, giving each subject a 50% chance of being assigned to the control group.
Trial Group: Subjects will receive oxycodone hydrochloride injection at a dose of 0.03-0.2 mg/kg/h. Pain scores will be assessed every 15 minutes until the CPOT (Critical Care Pain Observation Tool) score is less than 3. After achieving the target pain score, pain scores will be assessed every 4 hours.
Control Group: Subjects will receive remifentanil hydrochloride injection at a dose of 2-9 μg/kg/h. Pain scores will be assessed every 15 minutes until the CPOT score is less than 3. After achieving the target pain score, pain scores will be assessed every 4 hours.
During this period, the vital signs and monitoring data of the subjects will be recorded. Analgesia and sedation scores will be recorded from days 1 to 7 after administration, and the analgesic and sedative drug dosages will be adjusted based on the subjects' pain scores. Additionally, the incidence of adverse reactions and changes in gastrointestinal function will be observed and recorded from days 1 to 7 after administration.
There are no biological detection indicators in this study; all evaluations are made by the researchers through scoring sheets and will not affect the subjects' normal treatment. If a subject is extubated and weaned off the ventilator within 7 days, relevant data will be collected based on the time of extubation. On the 28th day after administration, doctors will follow up via the electronic medical record system to gather data on the extubation success rate, incidence of complications, and other relevant indicators within the 28-day period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone Hydrochloride | Experimental | Continuous infusion therapy |
|
| Remifentanil | Active Comparator | Continuous infusion therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone Hydrochloride | Drug | Oxycodone hydrochloride will be administered at a continuous infusion dose of 0.03-0.2 mg/kg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time with Critical care Pain Observation Tool (CPOT) < 3 without rescue analgesia within 7 days of mechanical ventilation. | By CPOT Form. | Mechanical ventilation within 7 days after administration of analgesics. |
| Measure | Description | Time Frame |
|---|---|---|
| Days without mechanical ventilation | Collect relevant data by case form | Within 28 days after administration |
| Successful extubation rate | Defined as not using non-invasive or invasive mechanical ventilation within 48 hours after the first spontaneous breathing trial (SBT) in 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunhang Zhang | Contact | 19542814786 | zhang.yunhang@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zhong | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | 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 |
|---|---|
| D010098 | Oxycodone |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Remifentanil | Drug | Remifentanil will be administered at a continuous infusion dose of 2-9 μg/kg/h. |
|
| Within 28 days after administration |
| Ventilator-associated pneumonia | Assessed according to diagnostic criteria | Within 28 days after administration |
| Delirium | Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU provides a binary outcome: the presence or absence of delirium. The assessment results in either a positive or negative diagnosis for delirium, where a positive result indicates the presence of delirium and a worse outcome for the patient. | Within 28 days after administration |
| Length of Stay (LOS) in ICU | Collect relevant data by case form | From ICU admission to ICU discharge (typically within 1 to 4 weeks) |
| Change in gastrointestinal function within 7 days of dosing | Gastrointestinal Failure (GIF) score. The score ranges from 0 to 4, a higher GIF score signifies a more severe gastrointestinal dysfunction and a worse outcome for the patient. | Postdose 1, 2, 3, 4, 5, 6, 7 days |
| Adverse Event (AE) incidence rate | Investigator assessment by observation | 7 days postdose |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |