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

Jun Wang

Status and phase: Completed; Phase 4

Conditions: Analgesia, Patient-Controlled

Treatments: Drug: intravenous hydromorphone and dexmedetomidine; Drug: subcutaneous hydromorphone; Drug: intravenous sufentanil; Drug: intravenous sufentanil and dexmedetomidine; Drug: intravenous hydromorphone; Drug: subcutaneous sufentanil; Drug: subcutaneous sufentanil and dexmedetomidine; Drug: subcutaneous hydromorphone and dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04111328

2019-191-2

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 8 patient groups

sufentanil administration intravenously

Experimental group

Description:

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.

Treatment:

Drug: intravenous sufentanil

sufentanil administration subcutaneously

Experimental group

Description:

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.

Treatment:

Drug: subcutaneous sufentanil

hydromorphone administration intravenously

Experimental group

Description:

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.

Treatment:

Drug: intravenous hydromorphone

hydromorphone administration subcutaneously

Experimental group

Description:

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.

Treatment:

Drug: subcutaneous hydromorphone

sufentanil and dexmedetomidine intravenously

Experimental group

Description:

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.

Treatment:

Drug: intravenous sufentanil and dexmedetomidine

sufentanil and dexmedetomidine subcutaneously

Experimental group

Description:

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.

Treatment:

Drug: subcutaneous sufentanil and dexmedetomidine

hydromorphone and dexmedetomidine intravenously

Experimental group

Description:

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.

Treatment:

Drug: intravenous hydromorphone and dexmedetomidine

hydromorphone and dexmedetomidine subcutaneously

Experimental group

Description:

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.

Treatment:

Drug: subcutaneous hydromorphone and dexmedetomidine