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

Phase 4

Completed

• Conditions: Analgesia, Patient-Controlled
• Interventions: Drug: intravenous hydromorphone and dexmedetomidine; Drug: subcutaneous sufentanil; Drug: subcutaneous sufentanil and dexmedetomidine; Drug: intravenous sufentanil; Drug: intravenous hydromorphone; Drug: subcutaneous hydromorphone; Drug: intravenous sufentanil and dexmedetomidine; Drug: subcutaneous hydromorphone and dexmedetomidine

• Registration Number: NCT04111328
• Lead Sponsor: Jun Wang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-01
• Study Start: 2019-10-08
• Status Verified: 2020-07
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-30
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydromorphone and dexmedetomidine intravenously	intravenous hydromorphone and dexmedetomidine	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.
sufentanil administration subcutaneously	subcutaneous sufentanil	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.
sufentanil and dexmedetomidine subcutaneously	subcutaneous sufentanil and dexmedetomidine	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.
sufentanil administration intravenously	intravenous sufentanil	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.
hydromorphone administration intravenously	intravenous hydromorphone	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	subcutaneous hydromorphone	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.
sufentanil and dexmedetomidine intravenously	intravenous sufentanil and dexmedetomidine	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.
hydromorphone and dexmedetomidine subcutaneously	subcutaneous hydromorphone and dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale of Comfort level	48 hours after the use of PCA.	The participants' comfort level of the PCA."0" means extremely comfort, "10" means extremely discomfort.

Secondary Outcome Measures

Name	Time	Method
Ramsay sedation score	6hours,12hours,24hours and 48 hours after the use of PCA.	To evaluate the degree of sedation.
The degree of nausea	6hours,12hours,24hours and 48 hours after the use of PCA.	"0" means no nausea and vomiting,"1" means only nausea,"2"means nausea and vomiting .
The degree of dizziness	6hours,12hours,24hours and 48 hours after the use of PCA.	"0" means no dizziness,"1" means the time of dizziness less than 2 hours,"2" means the time of dizziness more than 2 hours.
Pupil diameter	6hours,12hours,24hours and 48 hours after the use of PCA.	The average diameter of both pupils measuring by pupil pen.

Trial Locations

Locations (1)

The First Affiliated Hosipital of China Medical University; 🇨🇳 Shenyang, Liaoning, China