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To explore the effect of different drugs and infusion ways on degree of postoperative comfort.Patients undergoing spinal neoplasm surgery receive different patient controlled analgesia(PCA) drugs postoperatively,one group is sufentanil,the other is hydromorphone. Then each drug group will be divided into two subgroups according to the infusion way,intravenously,subcutaneously. During the patient controlled analgesia period, patients' degree of comfort,pain score,sleep quality, the degree of side reaction will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sufentanil administration intravenously | Experimental | The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min. |
|
| sufentanil administration subcutaneously | Experimental | The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min. |
|
| hydromorphone administration intravenously | Experimental | The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min. |
|
| hydromorphone administration subcutaneously | Experimental | The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous sufentanil | Drug | The PCA pumps contain sufentanil . And the pump is connected to participants intravenously . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale of Comfort level | The participants' comfort level of the PCA."0" means extremely comfort, "10" means extremely discomfort. | 48 hours after the use of PCA. |
| Measure | Description | Time Frame |
|---|---|---|
| Ramsay sedation score | To evaluate the degree of sedation. | 6hours,12hours,24hours and 48 hours after the use of PCA. |
| The degree of nausea | "0" means no nausea and vomiting,"1" means only nausea,"2"means nausea and vomiting . |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh sleep quality index | The quality of sleep. | 1 day before the surgery,1 month after the surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hosipital of China Medical University | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33952398 | Derived | Wang J, Cui L, Fan L, Wang J. Clinical Effect of Different Drugs and Infusion Techniques for Patient-controlled Analgesia After Spinal Tumor Surgery: A Prospective, Randomized, Controlled Clinical Trial. Clin Ther. 2021 Jun;43(6):1020-1028. doi: 10.1016/j.clinthera.2021.03.019. Epub 2021 May 2. |
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| sufentanil and dexmedetomidine intravenously |
| Experimental |
The dose of sufentanil, dexmedetomidine,for patient-controlled analgesia is 3.0μg/Kg, dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min. |
|
| sufentanil and dexmedetomidine subcutaneously | Experimental | The dose of sufentanil ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min. |
|
| hydromorphone and dexmedetomidine intravenously | Experimental | The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5ml/h, PCA dose 1ml, locking time 15 min. |
|
| hydromorphone and dexmedetomidine subcutaneously | Experimental | The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5ml/h, PCA dose 1 ml, locking time 15 min. |
|
| subcutaneous sufentanil | Drug | The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously. |
|
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| intravenous hydromorphone | Drug | The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously . |
|
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| subcutaneous hydromorphone | Drug | The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously. |
|
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| intravenous sufentanil and dexmedetomidine | Drug | The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously . |
|
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| subcutaneous sufentanil and dexmedetomidine | Drug | The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously. |
|
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| intravenous hydromorphone and dexmedetomidine | Drug | The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously. |
|
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| subcutaneous hydromorphone and dexmedetomidine | Drug | The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously |
|
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| 6hours,12hours,24hours and 48 hours after the use of PCA. |
| The degree of dizziness | "0" means no dizziness,"1" means the time of dizziness less than 2 hours,"2" means the time of dizziness more than 2 hours. | 6hours,12hours,24hours and 48 hours after the use of PCA. |
| Pupil diameter | The average diameter of both pupils measuring by pupil pen. | 6hours,12hours,24hours and 48 hours after the use of PCA. |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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