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| Name | Class |
|---|---|
| Wu Jieping Medical Foundation | OTHER |
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The goal of this clinical trial is to learn if Oliceridine fumarate injection works to treat acute pain after abdominal surgery. It will also learn about the safety of Oliceridine fumarate injection. The main questions it aims to answer are:
Researchers will compare Oliceridine fumarate injection to a positive-drug (Sufentanil Citrate) to see if Oliceridine fumarate injection not inferior to sufentanil in the efficacy and safety for acute pain after abdominal surgery.
Participants will:
Traditional opioid, such as morphine, sufentanil , is an important drug treatment of postoperative period of acute pain, but their use is often limited because of significant side effects, such as respiratory depression, postoperative nausea and vomiting and sedation. If a drug is effective treatment of postoperative pain and avoid these adverse reactions, it will shorten the postoperative recovery time of patients, increase patients' satisfaction, and reduce hospitalization costs. Basic research shows that traditional opioids mainly bind to μ-opioid receptors and activate G protein signal transduction to exert analgesic effect. In addition, they stimulate the recruitment of β-arrestin, leading to respiratory depression, nausea and vomiting and other side effects. Oliceridine is a newly μ-opioid receptor agonist, which mainly activates the G protein signaling pathway to exert analgesic effect, but has a weak recruitment effect on β-arrestin and thus reduces the incidence of adverse reactions. However, due to its recent introduction to the market, there is still a lack of large-scale clinical studies on the application of Oliceridine in the population. So this topic to discuss the analgesic efficacy and adverse reactions of Oliceridine in patients with acute pain after abdominal surgery. Our study hypothesized that Oliceridine would have comparable analgesic efficacy and a lower incidence of associated side effects than sufentanil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oliceridine | Experimental | In the experimental group, the acute pain after surgery will be treated with Oliceridine, Dexmedetomidine, Ondansetron via patient controlled analgesia for 48 hours. Oliceridine 0.4-0.6mg/kg, Dexmedetomidine 2ug/kg, and Ondansetron 16mg will be supplied to 100ml analgesia pump, loading dose for 2ml, background infusion dose for 1-2ml/h, bolus for 2ml/ time, locked for 15min, maximum dose for 12ml/h. |
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| Sufentanil | Active Comparator | In the control group, the acute pain after surgery will be treated with Sufentanil, Dexmedetomidine, and Ondansetron via patient controlled analgesia for 48 hours. Sufentanil 2ug/kg , Dexmedetomidine 2ug/kg, and Ondansetron 16mg will be supplied to 100ml analgesia pump, loading dose for 2ml, background infusion dose for 1-2ml/h, bolus for 2ml/ time, locked for 15min, maximum dose for 12ml/h. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oliceridine Injection [Olinvyk] | Drug | Oliceridine fumarate injection, specifications: 1mg/1mL, 2mg/2 mL, 10mg/10 mL; Stored in the dark, 15-30 ℃, not frozen; Jiangsu Nhwa pharmaceutical co., LTD. Production. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the pain intensity time curve (AUC0-48, time in hours) in resting and moving states as assessed by numerical rating scale(NRS) during postoperative 48 hours | Numerical rating scale(NRS), values from 0 to 10, 0 means "no pain", 10 means "the most intense pain", the higher score means a worse outcome; Area under the pain intensity time curve (AUC0-48), time in hours. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS during postoperative 12 hours and 24 hours. | Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS during postoperative 12 and 24 hours | 12 or 24 hours |
| total dose of rescue analgesics within 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| the analgesic effect and adverse reactions of Oliceridine in preoperative and postoperative hypertensive patients taking angiotensin-converting enzyme inhibitor/angiotensin receptor blocker(ACEI/ARB) drugs | the analgesic effect include the area under the pain intensity time curve (AUC, time in hours) in resting and moving states as assessed by numerical rating scale(NRS) at 12, 24 and 48 hours, the proportion of using rescue analgesics. The adverse reactions include the proportion of patients with nausea and vomiting within 48 hours and the proportion of patients using antiemetic drugs, the incidence of respiratory depression and the condition of sedation assessed by observer's assessment alert/Sedation(OAA/S). |
Inclusion Criteria:
1.Preoperative inclusion criteria
2.postoperative inclusion criteria:
Exclusion Criteria:
1.preoperative exclusion criteria:
6) suffering from mental or nervous system diseases (such as epilepsy, depression, schizophrenia, etc.), chronic obstructive pulmonary disease or pulmonary heart disease, heart failure, severe arrhythmia, etc; 7) with severe liver and kidney dysfunction; 8) Other conditions considered by the investigator to be inappropriate for enrollment.
Postoperative exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shinan deng, master | Contact | 18890362081 | 2667806135@qq.com | |
| e wang, doctor | Contact | 18874889950 | ewang324@163.com |
| Name | Affiliation | Role |
|---|---|---|
| e wang, doctor | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| 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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| Sufentanil Citrate | Drug | Sufentanil Citrate injection, specification: 50 ug/ml, 1 ml; Avoid light seal; Yichang humanwell pharmaceutical co., LTD. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml. |
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rescue analgesics include flurbiprofen axetil injection, parecoxib sodium and ketorolac tromethamine, reported in mg. |
| 48 hours or the liquid of pump has run out before 48 hours. |
| proportion of patients used rescue analgesics | proportion of patients used rescue analgesics | 48 hours or when the liquid of pump has run out before 48 hours. |
| Incidence of respiratory depression | Incidence of respiratory depression (i.e., respiratory rate ≤8 breaths/minute or oxygen saturation (SpO2)<90%) | 48 hours |
| The occurrence of nausea and vomiting | The proportion of patients with nausea and vomiting within 48 hours and the proportion of patients using antiemetic drugs. Antiemetic drugs (i.e., ondansetron or tropisetron) report in mg. | 48 hours |
| Condition of sedation | Condition of sedation is assessed by observer's assessment alert/Sedation(OAA/S), value from 0 to 5, grade 0 means deep sedation, grade 5 means fully awake. | 48 hours |
| the occurrence of adverse events | the occurrence of adverse events | 1 month |
| Satisfaction scores within 48 h of the participants and researchers | Satisfaction scores grade from 1 to 5. 5 means very satisfied, 4 means satisfied, 3 means general satisfied, 2 means not satisfied, 1 means very dissatisfied. | 48 hours |
| the use of Antiemetic drugs | the use of antiemetic drugs. | 48 hours |
| the score of quality of recovery-15 items | the score of quality of recovery-15 items(QoR-15) | 48 hours |
| 1 month |