the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort

Study Overview
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Brief Summary
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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.

Official Title
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the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery

Conditions
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Analgesia, Patient-Controlled

Intervention / Treatment
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* Drug: intravenous sufentanil
* Drug: subcutaneous sufentanil
* Drug: intravenous hydromorphone
* Drug: subcutaneous hydromorphone
* Drug: intravenous sufentanil and dexmedetomidine
* Drug: subcutaneous sufentanil and dexmedetomidine
* Drug: intravenous hydromorphone and dexmedetomidine
* Drug: subcutaneous hydromorphone and dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I or II . Exclusion Criteria: history of severe heart, hepatic or renal disease, history of chronic pain condition or opioid use, body mass index (BMI) ≤18 or ≥30 kg/m2, alcohol or drug abuse, relevant drug allergy, inability to properly describe postoperative pain, inability to use PCA pump.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sufentanil administration intravenously<br>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. | Drug: intravenous sufentanil<br>* The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .<br>* Other names: SI;|
| Experimental: sufentanil administration subcutaneously<br>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. | Drug: subcutaneous sufentanil<br>* The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.<br>* Other names: SS;|
| Experimental: hydromorphone administration intravenously<br>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. | Drug: intravenous hydromorphone<br>* The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .<br>* Other names: HI;|
| Experimental: hydromorphone administration subcutaneously<br>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. | Drug: subcutaneous hydromorphone<br>* The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.<br>* Other names: HS;|
| Experimental: sufentanil and dexmedetomidine intravenously<br>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. | Drug: intravenous sufentanil and dexmedetomidine<br>* The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .<br>* Other names: SDI;|
| Experimental: sufentanil and dexmedetomidine subcutaneously<br>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. | Drug: subcutaneous sufentanil and dexmedetomidine<br>* The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.<br>* Other names: SDS;|
| Experimental: hydromorphone and dexmedetomidine intravenously<br>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. | Drug: intravenous hydromorphone and dexmedetomidine<br>* The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.<br>* Other names: HDI;|
| Experimental: hydromorphone and dexmedetomidine subcutaneously<br>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. | Drug: subcutaneous hydromorphone and dexmedetomidine<br>* The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously<br>* Other names: HDS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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,2means nausea and vomiting . | 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. |