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

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ClinicalTrials.gov Identifier: NCT04111328
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Jun Wang, First Hospital of China Medical University

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.

Condition or disease Intervention/treatment Phase
Analgesia, Patient-Controlled 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 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: HDS




Primary Outcome Measures :
  1. Visual Analogue Scale of Comfort level [ Time Frame: 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 :
  1. Ramsay sedation score [ Time Frame: 6hours,12hours,24hours and 48 hours after the use of PCA. ]
    To evaluate the degree of sedation.

  2. The degree of nausea [ Time Frame: 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 .

  3. The degree of dizziness [ Time Frame: 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.

  4. Pupil diameter [ Time Frame: 6hours,12hours,24hours and 48 hours after the use of PCA. ]
    The average diameter of both pupils measuring by pupil pen.


Other Outcome Measures:
  1. Pittsburgh sleep quality index [ Time Frame: 1 day before the surgery,1 month after the surgery. ]
    The quality of sleep.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111328


Contacts
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Contact: Jiao Wang 8618240223963 wangjiao9210@163.com

Locations
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China, Liaoning
The First Affiliated Hosipital of China Medical University Recruiting
Shenyang, Liaoning, China
Contact: jiao wang    8618240223963    wangjiao9210@163.com   
Sponsors and Collaborators
Jun Wang
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Responsible Party: Jun Wang, Professor, First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT04111328    
Other Study ID Numbers: 2019-191-2
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020

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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
Additional relevant MeSH terms:
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Sufentanil
Dexmedetomidine
Hydromorphone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics