Analgesia, Patient-ControlledPhase 4NCT04111328
the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort
A Phase 4 study testing intravenous sufentanil, subcutaneous sufentanil and intravenous hydromorphone in people with Analgesia, Patient-Controlled, run by Jun Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Patient-Controlled
- What is being tested?
- intravenous sufentanil, subcutaneous sufentanil and intravenous hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2019to 30 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II .
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hosipital of China Medical University
Shenyang, Liaoning
About this study
Official title: 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.
- Conditions
- Analgesia, Patient-Controlled
- Being tested
- intravenous sufentanil, subcutaneous sufentanil, intravenous hydromorphone, subcutaneous hydromorphone, intravenous sufentanil and dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous sufentanilDrug
Also called SI
The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .
subcutaneous sufentanilDrug
Also called SS
The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.
intravenous hydromorphoneDrug
Also called HI
The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .
subcutaneous hydromorphoneDrug
Also called HS
The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.
intravenous sufentanil and dexmedetomidineDrug
Also called SDI
The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .
subcutaneous sufentanil and dexmedetomidineDrug
Also called SDS
The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.
intravenous hydromorphone and dexmedetomidineDrug
Also called HDI
The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.
subcutaneous hydromorphone and dexmedetomidineDrug
Also called HDS
The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| sufentanil administration intravenously | Experimental | 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. Receives: Drug: intravenous sufentanil |
| sufentanil administration subcutaneously | Experimental | 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. Receives: Drug: subcutaneous sufentanil |
| hydromorphone administration intravenously | Experimental | 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. Receives: Drug: intravenous hydromorphone |
| hydromorphone administration subcutaneously | Experimental | 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. Receives: Drug: subcutaneous hydromorphone |
| sufentanil and dexmedetomidine intravenously | Experimental | 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. Receives: Drug: intravenous sufentanil and dexmedetomidine |
| sufentanil and dexmedetomidine subcutaneously | Experimental | 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. Receives: Drug: subcutaneous sufentanil and dexmedetomidine |
| hydromorphone and dexmedetomidine intravenously | Experimental | 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. Receives: Drug: intravenous hydromorphone and dexmedetomidine |
| hydromorphone and dexmedetomidine subcutaneously | Experimental | 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. Receives: Drug: subcutaneous hydromorphone and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale of Comfort level
The participants' comfort level of the PCA."0" means extremely comfort, "10" means extremely discomfort.
Measured: 48 hours after the use of PCA.
Secondary outcomes (4)
Ramsay sedation score
To evaluate the degree of sedation.
Measured: 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 .
Measured: 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.
Measured: 6hours,12hours,24hours and 48 hours after the use of PCA.
Pupil diameter
The average diameter of both pupils measuring by pupil pen.
Measured: 6hours,12hours,24hours and 48 hours after the use of PCA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start8 Oct 2019
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia, Patient-ControlledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Wang, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111328
- Sponsor's protocol ID
- 2019-191-2
- Status last verified
- Jul 2020
- First submitted
- 25 Sep 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33952398
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery
- ClinicalTrials.gov ID
- NCT04111328
- Acronym / sponsor ID
- 2019-191-2
- Conditions
- Analgesia, Patient-Controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Jun WangUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| sufentanil administration intravenously | Experimental | Drug: intravenous sufentanilThe 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. |
| sufentanil administration subcutaneously | Experimental | Drug: subcutaneous sufentanilThe 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. |
| hydromorphone administration intravenously | Experimental | Drug: intravenous hydromorphoneThe 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 | Experimental | Drug: subcutaneous hydromorphoneThe 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 | Experimental | Drug: intravenous sufentanil and dexmedetomidineThe 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. |
| sufentanil and dexmedetomidine subcutaneously | Experimental | Drug: subcutaneous sufentanil and dexmedetomidineThe 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. |
| hydromorphone and dexmedetomidine intravenously | Experimental | Drug: intravenous hydromorphone and dexmedetomidineThe 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. |
| hydromorphone and dexmedetomidine subcutaneously | Experimental | Drug: subcutaneous hydromorphone and dexmedetomidineThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I or II .
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous sufentanilAlso: SIThe PCA pumps contain sufentanil . And the pump is connected to participants intravenously . | Drug | sufentanil administration intravenously |
| subcutaneous sufentanilAlso: SSThe PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously. | Drug | sufentanil administration subcutaneously |
| intravenous hydromorphoneAlso: HIThe PCA pumps contain hydromorphone. And the pump is connected to participants intravenously . | Drug | hydromorphone administration intravenously |
| subcutaneous hydromorphoneAlso: HSThe PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously. | Drug | hydromorphone administration subcutaneously |
| intravenous sufentanil and dexmedetomidineAlso: SDIThe PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously . | Drug | sufentanil and dexmedetomidine intravenously |
| subcutaneous sufentanil and dexmedetomidineAlso: SDSThe PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously. | Drug | sufentanil and dexmedetomidine subcutaneously |
| intravenous hydromorphone and dexmedetomidineAlso: HDIThe PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously. | Drug | hydromorphone and dexmedetomidine intravenously |
| subcutaneous hydromorphone and dexmedetomidineAlso: HDSThe PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously | Drug | hydromorphone and dexmedetomidine subcutaneously |
Primary outcome
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.
4 secondary outcomes
Ramsay sedation score
Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.
The degree of nausea
Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.
The degree of dizziness
Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.
Pupil diameter
Time frame: 6hours,12hours,24hours and 48 hours after the use of PCA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 33952398Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous sufentanil, subcutaneous sufentanil and intravenous hydromorphone in people with Analgesia, Patient-Controlled, run by Jun Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of Comfort level (time frame: 48 hours after the use of PCA.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04111328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.