Respiratory InsufficiencyPhase 4NCT05024799
Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation
A Phase 4 study testing Fentanyl, propofol, fentanyl and dexmedetomindine and Butorphanol and propofol in people with Respiratory Insufficiency, run by The Affiliated Hospital of Qingdao University.
Trial summary
Most patients in ICU are treated with a combination of analgesics and sedatives in most cases. Due to the different mechanism of different sedative and analgesic drugs, different antagonistic or synergistic effects may occur when combined with drugs, resulting in different clinical effects, especially significant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Fentanyl, propofol, fentanyl and dexmedetomindine and Butorphanol and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2024
- 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
- Adults who are treated with sedation and analgesia for invasive mechanical ventilation
Who cannot join
- they have baseline severe cognitive impairment; were pregnant or breast-feeding; were blind, deaf ; had second-degree or third-degree heart block or bradycardia requiring intervention; had an allergy to the experimental drugs; had an indication for benzodiazepines; were anticipated to have immediate discontinuation of mechanical ventilation; were expected to have neuromuscular blockade for more than 48 hours; were in a moribund state; or had received mechanical ventilation for more than 96 hours before meeting all inclusion criteria.
Trial locations and contacts
No sites are listed yet.
About this study
Most patients in ICU are treated with a combination of analgesics and sedatives in most cases. Due to the different mechanism of different sedative and analgesic drugs, different antagonistic or synergistic effects may occur when combined with drugs, resulting in different clinical effects, especially significant effects on ventilators for patients with assisted breathing. Therefore, this study hopes to compare the effects of different sedative and analgesic drug combinations on the duration of mechanical ventilation for patients with ventilators, so as to guide the clinical adoption of a more reasonable sedative and analgesic scheme.
- Conditions
- Respiratory Insufficiency
- Being tested
- Fentanyl, propofol, fentanyl and dexmedetomindine, Butorphanol and propofol, Butorphanol and dexmedetomindine
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl, propofolDrug
The patients in this group will be administered with fentanyl and propofol
fentanyl and dexmedetomindineDrug
The patients in this group will be administered with fentanyl and dexmedetomindine
Butorphanol and propofolDrug
The patients in this group will be administered with butorphanol and propofol
Butorphanol and dexmedetomindineDrug
The patients in this group will be administered with butorphanol and dexmedetomindine
| Study group | Role | What they receive |
|---|---|---|
| F-P group | Experimental | the combination of fentanyl and propofol Receives: Drug: Fentanyl, propofol |
| F-D group | Experimental | the combination of fentanyl and dexmedetomidine Receives: Drug: fentanyl and dexmedetomindine |
| B-P group | Experimental | the combination of butorphanol and propofol Receives: Drug: Butorphanol and propofol |
| B-D group | Experimental | the combination of butorphanol and dexmedetomidine Receives: Drug: Butorphanol and dexmedetomindine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator-free days at 28 days
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study startJan 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JinyanXing, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024799
- Sponsor's protocol ID
- QYFYKYLL931311920
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05024799
- Acronym / sponsor ID
- QYFYKYLL931311920
- Conditions
- Respiratory Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Aug 2021 (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.
Most patients in ICU are treated with a combination of analgesics and sedatives in most cases. Due to the different mechanism of different sedative and analgesic drugs, different antagonistic or synergistic effects may occur when combined with drugs, resulting in different clinical effects, especially significant effects on ventilators for patients with assisted breathing. Therefore, this study hopes to compare the effects of different sedative and analgesic drug combinations on the duration of mechanical ventilation for patients with ventilators, so as to guide the clinical adoption of a more reasonable sedative and analgesic scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| F-P group | Experimental | Drug: Fentanyl, propofolthe combination of fentanyl and propofol |
| F-D group | Experimental | Drug: fentanyl and dexmedetomindinethe combination of fentanyl and dexmedetomidine |
| B-P group | Experimental | Drug: Butorphanol and propofolthe combination of butorphanol and propofol |
| B-D group | Experimental | Drug: Butorphanol and dexmedetomindinethe combination of butorphanol and dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults who are treated with sedation and analgesia for invasive mechanical ventilation
Key exclusion criteria (1 listed)
- they have baseline severe cognitive impairment; were pregnant or breast-feeding; were blind, deaf ; had second-degree or third-degree heart block or bradycardia requiring intervention; had an allergy to the experimental drugs; had an indication for benzodiazepines; were anticipated to have immediate discontinuation of mechanical ventilation; were expected to have neuromuscular blockade for more than 48 hours; were in a moribund state; or had received mechanical ventilation for more than 96 hours before meeting all inclusion criteria.
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 |
|---|---|---|
| Fentanyl, propofolThe patients in this group will be administered with fentanyl and propofol | Drug | F-P group |
| fentanyl and dexmedetomindineThe patients in this group will be administered with fentanyl and dexmedetomindine | Drug | F-D group |
| Butorphanol and propofolThe patients in this group will be administered with butorphanol and propofol | Drug | B-P group |
| Butorphanol and dexmedetomindineThe patients in this group will be administered with butorphanol and dexmedetomindine | Drug | B-D group |
Primary outcome
ventilator-free days at 28 days
Time frame: at 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl, propofol, fentanyl and dexmedetomindine and Butorphanol and propofol in people with Respiratory Insufficiency, run by The Affiliated Hospital of Qingdao University.
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 1 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jinyan Xing, Dr (86-0532-82919386 ext. 82919386, xingjy@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator-free days at 28 days (time frame: at 28 days). 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 27 Aug 2021.