AnalgesiaPhase 4NCT04315935
Comparison of Analgesic Effect and Prognosis of Butorphanol and Fentanyl in Patients With Mechanical Ventilation
A Phase 4 study testing Butorphanol and Propofol and Fentanyl and Propofol in people with Analgesia, run by Jiangsu Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
ICU patients often in a strong stress environment. Various invasive procedures such as wound dressing change, sputum suction,Pull out the thoracic duct etc. At the same time, the diseases and environmental factors caused patients anxiety, pain, delirium and even a series of pathophysiological changes which harm life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Butorphanol and Propofol and Fentanyl and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2019to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged >= 18 years, 18kg / m2 < BMI < 30 kg / m2;
- patients with invasive mechanical ventilation (refer to the clinical application guide of mechanical ventilation [2006];
- the expected ventilation time was >= 24h, and the ventilation time was < 48h;
- sign the informed consent voluntarily and participate in the research. -
Who cannot join
- known allergy to any study drug;
- for chronic pain of grade 3 or above in the World Health Organization, strong opioids, such as morphine, are often used. Recently, opioids are used for analgesia through spinal cord catheter, epidural or any other regional block;
- the American Society of anesthesiologists (ASA) classified the fifth grade patients (on the verge of death);
- nerve injury or brain organic pathological changes;
- participate in clinical research in the past 30 days;
- pregnancy or lactation;
- the researcher thinks it is not suitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei People's Hospital
Hebei, Hebei
Quansheng Q Du, doctor, +86 13230163769 ext. 13230163769, dqs888@126.com
Jun J Ren, master, +86 18205138967 ext. 18205138967, renjun8967@163.com
About this study
Official title: Comparison of Analgesic Effect and Prognosis of Butorphanol and Fentanyl in Patients With Mechanical Ventilation: a Prospective, Randomized, Multicenter Clinical Study
ICU patients often in a strong stress environment. Various invasive procedures such as wound dressing change, sputum suction,Pull out the thoracic duct etc. At the same time, the diseases and environmental factors caused patients anxiety, pain, delirium and even a series of pathophysiological changes which harm life and safety. Fentanyl is an analgesic that acts on central μ receptors, clinical practice had found that fentanyl could exert analgesic effects, while it maybe affect patients' hemodynamics, breathing, and nervous system, which caused hypotension, bradycardia, respiratory depression, delirium and other adverse drug reactions. These reactions prolonged the mechanical ventilation time and duration time of patients in hospital, which impact the treatment effect and prognosis of patients. Butorphanol tartrate is a new type of opioid receptor agonist and antagonist, which can stimulate the κ receptor, and also certain stimulated and antagonised effects on the μ receptor. It can be used for analgesia and sedation in patients of ICU. Previous studies shown that butorphanol can inhibit the inflammatory response and effect myocardial protective. The analgesic effect of butorphanol were equivalent to fentanyl in patients of ICU, and the incidence of nausea and vomiting in participants with butorphanol less than fentanyl. Therefore, the investigators speculate that the analgesia of butorphanol in ICU patients may unexpected effects. However, butorphanol and fentanyl on the analgesic effect and prognosis of patients with mechanical ventilation in ICU are lacking currently, and the investigators no corresponding multi-center clinical study at home and abroad. The research compare to the analgesic effect of butorphanol and fentanyl in critically ill patients with mechanical ventilation. Effects of butorphanol and fentanyl on mechanical ventilation duration, sedation depth, duration time of patients in hospital, complications and mortality in patients with mechanical ventilation. To analyze the high-risk factors affecting the prognosis of patients with mechanical ventilation in ICU. Found more treatment measures for analgesia of patients with mechanical ventilation in ICU.
Read the detailed description
For enrolled patients, the investigators required that inclusion criteria were informed consent signed.The exclusion criteria were described in detail in the CRF standard. The recruitment of patients into the group were conducted in each sub-center according to Inclusion criteria. After the inclusion of patients will registed relevant information according to the basic data table of patients, disease information table and baseline data table, and then randomly divide the patients into groups by special statistician (CRA/CRO).The relevant data in the clinical study were collected by specialized nurses or data recording team.The daily statistical results need to record and dated by statisticians in order to track the authenticity and reliability of the data. The statistician should communicate with the doctor in charge about the situation out the trial plan during the study. If there is any change in the test plan, it is necessary to mark the measures and reasons for the change in detail, and sign the signature and date of the statistician and the responsible doctor in the statistical table of the day. The recorded data of the study should be updated with electronic documents. Statistical recorder of data need to make weekly summary, summarize and submit the statistical data of last month at each sub-research center at the beginning of each month, then the lead hospital will summarize and analyze the data.As for the problems beyond the experimental schemes in the research process, each branch center needs to discuss with the lead center. Every three months, progress meetings will be held to discuss various problems in clinical research and to unify standards for related problems to ensure the smooth progress of clinical research and the true reliability of experimental results. SAS 9.4 software was used for statistical analysis. The analysis content included subject distribution description, baseline index balance analysis, efficacy analysis and safety analysis.The significance level of the statistical test was α=0.05. In the safety analysis, the incidence of adverse events and adverse reactions was calculated and the specific conditions of all subjects with adverse events were listed. The list of vital signs and normal abnormalities in laboratory examination before and after medication was described, and the specific conditions of subjects with abnormal conditions before and after treatment and abnormal conditions before and after treatment were listed in detail.After completing the statistical analysis, the statistical analyst should record the data and submit it to the main researcher of the experiment to fill with the general analysis report. All cases, whether observation or shedding, should be completed in accordance with the requirements of "case report form". The case report form were copied three copies with without carbon copy. After the completion of data entry, the sponsor (the first copy), the unit in charge of the clinical research (the second copy) and the clinical research unit (the third copy) shall file it respectively.
- Conditions
- Analgesia
- Being tested
- Butorphanol and Propofol, Fentanyl and Propofol
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butorphanol and PropofolDrug
The two groups were given propofol for sedation, BG for butorphanol for analgesia and FG for fentanyl for analgesia
Fentanyl and PropofolDrug
Fentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation
| Study group | Role | What they receive |
|---|---|---|
| butorphanol group | Experimental | Butorphanol (10-20 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation Receives: Drug: Butorphanol and Propofol |
| fentanyl group | Active comparator | Fentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation Receives: Drug: Fentanyl and Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic score,
Analgesia score (CPOT < 3 points)
Measured: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
sedative score
APACHE II score, SOFA score,
Measured: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
Total dosage of butorphanol， fentanyl，propofol;
The specific dosage of butorphanol, fentanyl and propofol,
Measured: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
Secondary outcomes (1)
Major indicators affecting the prognosis of patients in ICU
pulling time, ICU stay time, invasive mechanical ventilation time, length of stay, 30 day mortality
Measured: From day 1 to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start15 Dec 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Quansheng Q Du, doctor, Principal investigator, Hebei People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315935
- Sponsor's protocol ID
- SINGCHN-BUT-IV-1902
- Status last verified
- Mar 2020
- First submitted
- 14 Jan 2020
- Last updated
- 20 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The clinical study data of this project were owned by the participating research center. For other researchers who need data, the results of the study can be understood through the literature published later.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effect and Prognosis of Butorphanol and Fentanyl in Patients With Mechanical Ventilation: a Prospective, Randomized, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT04315935
- Acronym / sponsor ID
- SINGCHN-BUT-IV-1902
- Conditions
- Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Jiangsu Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Mar 2020 (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.
ICU patients often in a strong stress environment. Various invasive procedures such as wound dressing change, sputum suction,Pull out the thoracic duct etc. At the same time, the diseases and environmental factors caused patients anxiety, pain, delirium and even a series of pathophysiological changes which harm life and safety. Fentanyl is an analgesic that acts on central μ receptors, clinical practice had found that fentanyl could exert analgesic effects, while it maybe affect patients' hemodynamics, breathing, and nervous system, which caused hypotension, bradycardia, respiratory depression, delirium and other adverse drug reactions. These reactions prolonged the mechanical ventilation time and duration time of patients in hospital, which impact the treatment effect and prognosis of patients. Butorphanol tartrate is a new type of opioid receptor agonist and antagonist, which can stimulate the κ receptor, and also certain stimulated and antagonised effects on the μ receptor. It can be used for analgesia and sedation in patients of ICU. Previous studies shown that butorphanol can inhibit the inflammatory response and effect myocardial protective. The analgesic effect of butorphanol were equivalent to fentanyl in patients of ICU, and the incidence of nausea and vomiting in participants with butorphanol less than fentanyl. Therefore, the investigators speculate that the analgesia of butorphanol in ICU patients may unexpected effects. However, butorphanol and fentanyl on the analgesic effect and prognosis of patients with mechanical ventilation in ICU are lacking currently, and the investigators no corresponding multi-center clinical study at home and abroad. The research compare to the analgesic effect of butorphanol and fentanyl in critically ill patients with mechanical ventilation. Effects of butorphanol and fentanyl on mechanical ventilation duration, sedation depth, duration time of patients in hospital, complications and mortality in patients with mechanical ventilation. To analyze the high-risk factors affecting the prognosis of patients with mechanical ventilation in ICU. Found more treatment measures for analgesia of patients with mechanical ventilation in ICU.
Detailed description
For enrolled patients, the investigators required that inclusion criteria were informed consent signed.The exclusion criteria were described in detail in the CRF standard. The recruitment of patients into the group were conducted in each sub-center according to Inclusion criteria. After the inclusion of patients will registed relevant information according to the basic data table of patients, disease information table and baseline data table, and then randomly divide the patients into groups by special statistician (CRA/CRO).The relevant data in the clinical study were collected by specialized nurses or data recording team.The daily statistical results need to record and dated by statisticians in order to track the authenticity and reliability of the data. The statistician should communicate with the doctor in charge about the situation out the trial plan during the study. If there is any change in the test plan, it is necessary to mark the measures and reasons for the change in detail, and sign the signature and date of the statistician and the responsible doctor in the statistical table of the day. The recorded data of the study should be updated with electronic documents. Statistical recorder of data need to make weekly summary, summarize and submit the statistical data of last month at each sub-research center at the beginning of each month, then the lead hospital will summarize and analyze the data.As for the problems beyond the experimental schemes in the research process, each branch center needs to discuss with the lead center. Every three months, progress meetings will be held to discuss various problems in clinical research and to unify standards for related problems to ensure the smooth progress of clinical research and the true reliability of experimental results. SAS 9.4 software was used for statistical analysis. The analysis content included subject distribution description, baseline index balance analysis, efficacy analysis and safety analysis.The significance level of the statistical test was α=0.05. In the safety analysis, the incidence of adverse events and adverse reactions was calculated and the specific conditions of all subjects with adverse events were listed. The list of vital signs and normal abnormalities in laboratory examination before and after medication was described, and the specific conditions of subjects with abnormal conditions before and after treatment and abnormal conditions before and after treatment were listed in detail.After completing the statistical analysis, the statistical analyst should record the data and submit it to the main researcher of the experiment to fill with the general analysis report. All cases, whether observation or shedding, should be completed in accordance with the requirements of "case report form". The case report form were copied three copies with without carbon copy. After the completion of data entry, the sponsor (the first copy), the unit in charge of the clinical research (the second copy) and the clinical research unit (the third copy) shall file it respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| butorphanol group | Experimental | Drug: Butorphanol and PropofolButorphanol (10-20 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation |
| fentanyl group | Active comparator | Drug: Fentanyl and PropofolFentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged >= 18 years, 18kg / m2 < BMI < 30 kg / m2;
- patients with invasive mechanical ventilation (refer to the clinical application guide of mechanical ventilation [2006];
- the expected ventilation time was >= 24h, and the ventilation time was < 48h;
- sign the informed consent voluntarily and participate in the research. -
Key exclusion criteria (7 listed)
- known allergy to any study drug;
- for chronic pain of grade 3 or above in the World Health Organization, strong opioids, such as morphine, are often used. Recently, opioids are used for analgesia through spinal cord catheter, epidural or any other regional block;
- the American Society of anesthesiologists (ASA) classified the fifth grade patients (on the verge of death);
- nerve injury or brain organic pathological changes;
- participate in clinical research in the past 30 days;
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 |
|---|---|---|
| Butorphanol and PropofolThe two groups were given propofol for sedation, BG for butorphanol for analgesia and FG for fentanyl for analgesia | Drug | butorphanol group |
| Fentanyl and PropofolFentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation | Drug | fentanyl group |
Primary outcome
Analgesic score,
Time frame: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
Analgesia score (CPOT < 3 points)
sedative score
Time frame: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
APACHE II score, SOFA score,
Total dosage of butorphanol， fentanyl，propofol;
Time frame: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
The specific dosage of butorphanol, fentanyl and propofol,
1 secondary outcome
Major indicators affecting the prognosis of patients in ICU
Time frame: From day 1 to day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Individual participant dataSharing planned: No. The clinical study data of this project were owned by the participating research center. For other researchers who need data, the results of the study can be understood through the literature published later.
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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.
Quansheng Q Du, doctor principal investigator
Hebei People's Hospital
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 Butorphanol and Propofol and Fentanyl and Propofol in people with Analgesia, run by Jiangsu Hengrui Pharmaceutical Co., Ltd. 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 4 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: status not confirmed, as of the sponsor's last update on 20 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun J Ren, master (18205138967 ext. 18205138967, renjun8967@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic score, (time frame: Maintain target analgesia score (CPOT<3) from 100% time to 80% time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2020.