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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
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The goal of this clinical trial is to evaluate the effect of dezocine combined with sufentanil on postoperative recovery quality and analgesic effect in patients undergoing thoracic surgery. It will also learn about the safety of dezocine. Researchers will compare drug dezocine to Sufentanil to see if dezocine works to Improve postoperative pain and recovery quality for patients. Participants will undergo elective surgery and receive PCIA postoperatively,taking dezocine combine with sufentanil,or only sufentanil respectively. Visit the VAS score after connecting the analgesic pump 24h and 48h,and evaluate the Quality of Recovery
-15 score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | At the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. |
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| Control group | Other | At the end of the operation, sufentanil injection 3.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was immediately administered after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dezocine | Drug | At the end of the operation, dezocine 1.0 mg/kg + sufentanil 2.0 ug/kg (prepared as 200 ml, background volume 2 ml/h, single dose 2 ml/time, locking time 15 min) was uniformly administered by PCIA; 3 ml test dose was administered immediately after the analgesic pump was connected at the end of the operation, and continuous analgesia was performed for 48 hours after the operation. |
| Measure | Description | Time Frame |
|---|---|---|
| QoR-15 score at 24 hours after connection to analgesic pump | QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| QoR-15 score at 48 hours after connection to analgesic pump | QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good) | 48 hours |
| Proportion of patients with ≥ 8 points increase in QoR-15 score from baseline at 24hours and 48hours after connection to analgesic pump |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Feng | Contact | +86 181 1598 6602 | fengsw@yangzijiang.com |
| Name | Affiliation | Role |
|---|---|---|
| Kexuan Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangzhou | China |
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QoR-15 is Quality of recovery-15,score ranges from 0 (QoR extremely poor) to 150 (QoR extremely good) |
| 24 hours and 48 hours |
| Patient global impression of change score at 48 hours after connection to analgesia pump | 48 hours |
| Static NRS score at 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours after connection to analgesia pump | 2hours, 4hours, 6hours, 12hours, 24hours, 36hours, 48hours |
| Number of effective compressions of analgesic pump with in 48 hours after connection of analgesic pump | 48 hours |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C010827 | dezocine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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