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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia, Patient-Controlled
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Affiliated Hosipital of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sufentanil administration intravenously; 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; The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .; Other Names: SI
Experimental: sufentanil administration subcutaneously; 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; The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.; Other Names: SS
Experimental: hydromorphone administration intravenously; 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; The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .; Other Names: HI
Experimental: hydromorphone administration subcutaneously; 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; The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.; Other Names: HS
Experimental: sufentanil and dexmedetomidine intravenously; 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; The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .; Other Names: SDI
Experimental: sufentanil and dexmedetomidine subcutaneously; 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; The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.; Other Names: SDS
Experimental: hydromorphone and dexmedetomidine intravenously; 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; The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.; Other Names: HDI
Experimental: hydromorphone and dexmedetomidine subcutaneously; 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; The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously; Other Names: HDS

What is the study measuring?

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,"2"means 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh sleep quality index	The quality of sleep.	1 day before the surgery,1 month after the surgery.

Collaborators and Investigators

• Sponsor: Jun wang

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Dexmedetomidine; Sufentanil; Dsuvia; Hydromorphone
• Other Study ID Numbers: 2019-191-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No