Mechanical VentilationPhase 4NCT05014711
Compare the Effects of Remifentanil and Fentanyl on the Duration of Mechanical Ventilation of ICU Patients
A Phase 4 study testing Remifentanil and Fentanyl in people with Mechanical Ventilation, run by Capital Medical University at 1 site in China.
Trial summary
To verify whether remifentanil is more beneficial to reduce the duration of mechanical ventilation, shorten the interval from SBT to extubation, reduce the incidence of adverse events, reduce the workload of nursing staff, reduce the dosage of sedatives and ICU hospitalization costs, shorten the length of ICU… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Remifentanil and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Mar 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Oral endotracheal intubation requiring mechanical ventilation; and (2) 18-85 years old; and (3) expected to require mechanical ventilation for longer than 24 hours.
Who cannot join
- (1) Deep sedation is required (PaO2/FiO2 ≤100, loss of consciousness during treatment with muscle relaxants, status epilepticus, surgery or surgical conditions require absolute immobilization, severe brain injury with intracranial hypertension, therapeutic hypothermia, etc. And other clinical assessments need to maintain RASS<-2); (2) The time of using sedatives or opioid analgesics is longer than 1 week before enrollment; (3) ICU stay ≥ 1 week before enrollment; (4) Invasive mechanical ventilation time ≥ 48 hours before enrollment; (5) According to the condition of the disease, it is estimated that mechanical ventilation will be needed for too long, such as the accumulation of respiratory muscles in peripheral neuromuscular diseases, brainstem damage and respiratory center involvement; (6) Delirium, alcohol withdrawal symptoms or mental illness or use of antipsychotic drugs; (7) Severe abnormal liver function (Child-Pugh grade C); (8) Renal insufficiency requires renal replacement therapy; (9) Surgical treatment is required during mechanical ventilation (except for minor operations, such as lumbar puncture, ventricular drainage, etc.); (10) Allergy to study drugs or other contraindications; (11) Pregnant or lactating women; (12) Has been selected for other RCT tests; (13) The patient or the legally authorized person is unwilling to participate in the trial; (14) The investigator judged that the patient was not suitable for selection (such as severe hypotension; potential disputes, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Jian-Xin Zhou, MD, 861059978019, zhoujx.cn@icloud.com
About this study
Official title: Compare the Effects of Remifentanil and Fentanyl on the Duration of Mechanical Ventilation of ICU Patients: a Multi-centre, Randomized, Controlled Trial
To verify whether remifentanil is more beneficial to reduce the duration of mechanical ventilation, shorten the interval from SBT to extubation, reduce the incidence of adverse events, reduce the workload of nursing staff, reduce the dosage of sedatives and ICU hospitalization costs, shorten the length of ICU hospitalization, and reduce the short-term mortality.
Read the detailed description
Opioids are widely used for analgesia in the ICU, of which, fentanyl and remifentanil are the most commonly used. Compared with the two analgesics, fentanyl is relatively cheap, but it is metabolised by liver. Long-term infusion makes its half-life extended, and side effects increase significantly. Respiratory depression is the most serious side effect and may lead to re-intubation and even sudden death.
Remifentanil is a strong selective μ-opioid receptor agonist, rapidly metabolized by non-specific plasma and tissue esterases into inactive metabolites; it has very short context-sensitive half-life even after prolonged infusion or in patients with organ failure. Remifentanil is easy to titrate and provides excellent analgesia: it allows higher doses administration than are normally used with traditional opioids without concerns about accumulation or delayed recovery.
This feature is helpful for patients with mechanical ventilation to weaning and extubate early. Previous studies comparing the two drugs mainly focus on short-term postoperative application, and theoretically long-term use can better reflect the pharmacokinetic advantages of Remifentanil. So we designed this study.
- Conditions
- Mechanical Ventilation
- Being tested
- Remifentanil, Fentanyl
- Keywords
- mechanical ventilation, remifentanil, fentanyl, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called remifentanil hydrochloride
Before infusion, remifentanil is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min.
FentanylDrug
Also called Fentanyl citrate
Before infusion, fentanyl is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| remifentanil group | Experimental | After enrollment, remifentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed. Receives: Drug: Remifentanil |
| fentanil group | Active comparator | After enrollment, fentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of mechanical ventilation
from the time of enrollment to successful removal from the ventilator
Measured: the end point of time is successfully transferred out of ICU or death or 28 days after enrollment
Secondary outcomes (3)
Incidences of adverse events
delirium, severe hypotension, severe bradycardia, constipation, chills, nausea and vomiting, muscle rigidity, accidental extubation
Measured: 1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first.
the interval from SBT(Spontaneous Breathing Trial) to extubation
tracheal intubation has been successfully removed after the first SBT
Measured: the end point of time is successfully transferred out of ICU or death or 28 days after enrollment
dosages and costs of analgesic and sedative drugs
The consumption and cost of analgesic and sedative drugs in experimental group and control group
Measured: 1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Study chair, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014711
- Sponsor's protocol ID
- KY-2019-082-02
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effects of Remifentanil and Fentanyl on the Duration of Mechanical Ventilation of ICU Patients: a Multi-centre, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05014711
- Acronym / sponsor ID
- KY-2019-082-02
- Conditions
- Mechanical Ventilation
- Keywords
- mechanical ventilation, remifentanil, fentanyl, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 20 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.
To verify whether remifentanil is more beneficial to reduce the duration of mechanical ventilation, shorten the interval from SBT to extubation, reduce the incidence of adverse events, reduce the workload of nursing staff, reduce the dosage of sedatives and ICU hospitalization costs, shorten the length of ICU hospitalization, and reduce the short-term mortality.
Detailed description
Opioids are widely used for analgesia in the ICU, of which, fentanyl and remifentanil are the most commonly used. Compared with the two analgesics, fentanyl is relatively cheap, but it is metabolised by liver. Long-term infusion makes its half-life extended, and side effects increase significantly. Respiratory depression is the most serious side effect and may lead to re-intubation and even sudden death.
Remifentanil is a strong selective μ-opioid receptor agonist, rapidly metabolized by non-specific plasma and tissue esterases into inactive metabolites; it has very short context-sensitive half-life even after prolonged infusion or in patients with organ failure. Remifentanil is easy to titrate and provides excellent analgesia: it allows higher doses administration than are normally used with traditional opioids without concerns about accumulation or delayed recovery.
This feature is helpful for patients with mechanical ventilation to weaning and extubate early. Previous studies comparing the two drugs mainly focus on short-term postoperative application, and theoretically long-term use can better reflect the pharmacokinetic advantages of Remifentanil. So we designed this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remifentanil group | Experimental | Drug: RemifentanilAfter enrollment, remifentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed. |
| fentanil group | Active comparator | Drug: FentanylAfter enrollment, fentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Oral endotracheal intubation requiring mechanical ventilation; and (2) 18-85 years old; and (3) expected to require mechanical ventilation for longer than 24 hours.
Key exclusion criteria (1 listed)
- (1) Deep sedation is required (PaO2/FiO2 ≤100, loss of consciousness during treatment with muscle relaxants, status epilepticus, surgery or surgical conditions require absolute immobilization, severe brain injury with intracranial hypertension, therapeutic hypothermia, etc. And other clinical assessments need to maintain RASS<-2); (2) The time of using sedatives or opioid analgesics is longer than 1 week before enrollment; (3) ICU stay ≥ 1 week before enrollment; (4) Invasive mechanical ventilation time ≥ 48 hours before enrollment; (5) According to the condition of the disease, it is estimated that mechanical ventilation will be needed for too long, such as the accumulation of respiratory muscles in peripheral neuromuscular diseases, brainstem damage and respiratory center involvement; (6) Delirium, alcohol withdrawal symptoms or mental illness or use of antipsychotic drugs; (7) Severe abnormal liver function (Child-Pugh grade C); (8) Renal insufficiency requires renal replacement therapy; (9) Surgical treatment is required during mechanical ventilation (except for minor operations, such as lumbar puncture, ventricular drainage, etc.); (10) Allergy to study drugs or other contraindications; (11) Pregnant or lactating women; (12) Has been selected for other RCT tests; (13) The patient or the legally authorized person is unwilling to participate in the trial; (14) The investigator judged that the patient was not suitable for selection (such as severe hypotension; potential disputes, etc.)
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 |
|---|---|---|
| RemifentanilAlso: remifentanil hydrochlorideBefore infusion, remifentanil is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min. | Drug | remifentanil group |
| FentanylAlso: Fentanyl citrateBefore infusion, fentanyl is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min. | Drug | fentanil group |
Primary outcome
duration of mechanical ventilation
Time frame: the end point of time is successfully transferred out of ICU or death or 28 days after enrollment
from the time of enrollment to successful removal from the ventilator
3 secondary outcomes
Incidences of adverse events
Time frame: 1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first.
the interval from SBT(Spontaneous Breathing Trial) to extubation
Time frame: the end point of time is successfully transferred out of ICU or death or 28 days after enrollment
dosages and costs of analgesic and sedative drugs
Time frame: 1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Jian-Xin Zhou, MD study chair
Capital Medical University
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 Remifentanil and Fentanyl in people with Mechanical Ventilation, run by Capital Medical University 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 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 20 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD (861059978019, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of mechanical ventilation (time frame: the end point of time is successfully transferred out of ICU or death or 28 days after enrollment). 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 Aug 2021.