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Traditional opioid analgesia is a treatment method for moderate to severe pain. However, the use of opioid drugs is not without risks. When treating acute pain, patients may experience hypotension, respiratory depression, hypoxia, nausea and vomiting, irritability, and itching. The purpose of this study is to evaluate the comparison of G protein biased μ - opioid receptor agonist oliceridine and traditional μ - opioid receptor agonist sufentanil in terms of analgesia in patients under general anesthesia.
All patients who met the inclusion criteria were randomly divided into two groups based on the use of postoperative analgesic pumps: the sufentanil group and the oliceridine group. The sufentanil group received a treatment regimen of sufentanil 2 µ g · kg-1; The treatment regimen for the oliceridine group is oliceridine 0.4mg · kg-1. The main postoperative observation indicator is the measurement of total pain intensity difference within 48 hours (SPID-48).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oliceridine group | Experimental | Oliceridine 0.4mg · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. PCIA is set to continuous infusion of 2ml/h, with a single dose of 2ml and a locking time of 15 minutes. |
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| Sufentanil group | Active Comparator | Sufentanil 2 µ g · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. PCIA is set to continuous infusion of 2ml/h, with a single dose of 2ml and a locking time of 15 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oliceridine | Drug | The formula for postoperative analgesia pump is oliceridine 0.4mg · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Total Pain Intensity Difference within 48 Hours (SPID-48) | Postoperative pain was evaluated using the NRS Pain Digital Rating Scale at 1, 6, 12, 24, 36, and 48 hours post surgery; Multiply the difference in pain intensity at each post baseline time point within 48 hours (subtracting the pain intensity at a specific post baseline time point from the pain intensity at baseline) by the duration (in hours) of the previous time point, and then add them up. | 48hour |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reactions | Incidence of nausea, vomiting, dizziness, headache, constipation, itching, and hypoxia | 48hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ningning Fu | Contact | 8618790658707 | 736508728@qq.com | |
| Jiaqiang Zhang | Contact | 8613937121360 | Jiaqiang197628@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiaqiang Zhang | Chief physician | Study Director |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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All patients who met the inclusion criteria were randomly divided into two groups based on the use of postoperative analgesic pumps: the sufentanil group and the oliceridine group. The sufentanil group received a treatment regimen of sufentanil 2 µ g · kg-1; The treatment regimen for the oliceridine group is oliceridine 0.4mg · kg-1.
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| Sulfentanil | Drug | The analgesic regimen for the sufentanil group is sufentanil 2 µ g · kg-1+tropisetron 10mg, mixed with physiological saline to 100ml. |
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