NIV IntoleranceNCT04734418
Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance
A study testing Remifentanil and Dexmedetomidine in people with NIV Intolerance, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NIV Intolerance
- What is being tested?
- Remifentanil and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2021to 28 Feb 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form voluntarily and follow the plan requirements;
- Age from 18 to 75 years old (including 18 and 75 years old), regardless of gender;
- Patients who received non-invasive mechanical ventilation after cardiac surgery and were intolerant of non-invasive ventilation.
Who cannot join
- A history of allergy to any component of the study drug;
- Visual analogue scale of pain (VAS) score >4；
- Who had taken dexmedetomidine within 8 hours prior to the study;
- Who had used remifentanil within 2 hours before the study began;
- Expectoration difficulties;
- Women who are pregnant or lactating;
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- Coma or uncontrollable convulsions;
- Have a history of mental illness or cognitive impairment;
- Delirium before the study began;
- Patients with severe liver dysfunction (CTP grade C);
- Patients with renal insufficiency (patients receiving renal replacement therapy);
- Preoperative left ventricular ejection fraction (LVEF) < 30%;
- History of drug and alcohol abuse;
- Other conditions that the investigator deems inappropriate for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Guo-wei Tu, Doctor, 86-13501996995, tu.guowei@zs-hospital.sh.cn
Guo-wei Tu, doctor
About this study
Official title: Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance After Cardiac Surgery: a Multicenter, Prospective, Single-blind, Randomized Controlled Study
Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which eventually leads to the failure of non-invasive ventilation.The patient's intubation rate is as high as 44%, and the mortality rate is 34%.There are many ways to prevent or treat NIV intolerance, of which the most used is to sedate the patient. This study aims to evaluate the effects of remifentanil and dexmedetomidine in the sedation of patients with intolerance to non-invasive mechanical ventilation after cardiac surgery, and to explore the optimal plan for sedation of patients with intolerant non-invasive mechanical ventilation after cardiac surgery.
- Conditions
- NIV Intolerance
- Being tested
- Remifentanil, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Intravenous pump injection.The initial dose of remifentanil is 0.05 μg/kg/min.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of remifentanil is 0.12 μg/kg/min
DexmedetomidineDrug
Intravenous pump injection.The initial dose of dexmedetomidine is 0.5 μg/kg/h.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of dexmedetomidine is 1.0 μg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil group | Experimental | Not described Receives: Drug: Remifentanil |
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine.
Measured: Within 72 hours of study drug used
Secondary outcomes (7)
Mortality in both remifentanil and dexmedetomidine group
Measured: Up to 30 days
Mechanical ventilation time in both remifentanil and dexmedetomidine group
Measured: Up to 30 days
Hemodynamic changes in both remifentanil and dexmedetomidine group
Measured: Up to 30 days
Incidence of delirium in both remifentanil and dexmedetomidine group
Measured: Up to 30 days
Days in ICU in both remifentanil and dexmedetomidine group
Measured: Up to 30 days
Intubation rate in both remifentanil and dexmedetomidine group
Measured: Up to 30 days
Tracheotomy rate in both remifentanil and dexmedetomidine group
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start8 Mar 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NIV IntoleranceStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guowei Tu, Shanghai Zhongshan Hospital
- Investigators
- Zhe Luo, MD PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734418
- Sponsor's protocol ID
- REDNIVI
- Status last verified
- Mar 2021
- First submitted
- 22 Jan 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hao GW, Luo JC, Xue Y, Ma GG, Su Y, Hou JY, Yu SJ, Liu K, Zheng JL, Tu GW, Luo Z. Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study. J Thorac Dis. 2020 Oct;12(10):5857-5868. doi: 10.21037/jtd-20-1678.
PubMed 33209418Hao GW, Wu JQ, Yu SJ, Liu K, Xue Y, Gong Q, Xie RC, Ma GG, Su Y, Hou JY, Zhang YJ, Liu WJ, Li W, Tu GW, Luo Z. Remifentanil vs. dexmedetomidine for cardiac surgery patients with noninvasive ventilation intolerance: a multicenter randomized controlled trial. J Intensive Care. 2024 Sep 18;12(1):35. doi: 10.1186/s40560-024-00750-2.
PubMed 39294818Deng YZ, Luo MH, Luo JC, Li JK, Chen JQ, Zhang YJ, Hou JY, Su Y, Tu GW, Luo Z. Postoperative glucocorticoids in patients with acute type A aortic dissection (GLAD): study protocol for a prospective, single-center, randomized controlled trial. BMC Anesthesiol. 2023 May 15;23(1):164. doi: 10.1186/s12871-023-02124-x.
PubMed 37189085Luo MH, Hao GW, Liu K, Yin K, Yu SJ, Wang H, Su Y, Luo JC, Wei YQ, Wang YH, Pan WQ, Tu GW, Luo Z. Remifentanil versus Dexmedetomidine in Cardiac Surgery Patients with Noninvasive Ventilation Intolerance: Protocol for the REDNIVI Trial. Rev Cardiovasc Med. 2022 Mar 4;23(3):84. doi: 10.31083/j.rcm2303084.
PubMed 35345251
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance After Cardiac Surgery: a Multicenter, Prospective, Single-blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04734418
- Acronym / sponsor ID
- REDNIVI
- Conditions
- NIV Intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 2 Feb 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.
Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which eventually leads to the failure of non-invasive ventilation.The patient's intubation rate is as high as 44%, and the mortality rate is 34%.There are many ways to prevent or treat NIV intolerance, of which the most used is to sedate the patient. This study aims to evaluate the effects of remifentanil and dexmedetomidine in the sedation of patients with intolerance to non-invasive mechanical ventilation after cardiac surgery, and to explore the optimal plan for sedation of patients with intolerant non-invasive mechanical ventilation after cardiac surgery.
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: Remifentanil |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sign the informed consent form voluntarily and follow the plan requirements;
- Age from 18 to 75 years old (including 18 and 75 years old), regardless of gender;
- Patients who received non-invasive mechanical ventilation after cardiac surgery and were intolerant of non-invasive ventilation.
Key exclusion criteria (14 listed)
- A history of allergy to any component of the study drug;
- Visual analogue scale of pain (VAS) score >4；
- Who had taken dexmedetomidine within 8 hours prior to the study;
- Who had used remifentanil within 2 hours before the study began;
- Expectoration difficulties;
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 |
|---|---|---|
| RemifentanilIntravenous pump injection.The initial dose of remifentanil is 0.05 μg/kg/min.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of remifentanil is 0.12 μg/kg/min | Drug | Remifentanil group |
| DexmedetomidineIntravenous pump injection.The initial dose of dexmedetomidine is 0.5 μg/kg/h.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of dexmedetomidine is 1.0 μg/kg/h. | Drug | Dexmedetomidine |
Primary outcome
Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine.
Time frame: Within 72 hours of study drug used
7 secondary outcomes
Mortality in both remifentanil and dexmedetomidine group
Time frame: Up to 30 days
Mechanical ventilation time in both remifentanil and dexmedetomidine group
Time frame: Up to 30 days
Hemodynamic changes in both remifentanil and dexmedetomidine group
Time frame: Up to 30 days
Incidence of delirium in both remifentanil and dexmedetomidine group
Time frame: Up to 30 days
Days in ICU in both remifentanil and dexmedetomidine group
Time frame: Up to 30 days
Intubation rate in both remifentanil and dexmedetomidine group
Time frame: Up to 30 days
Tracheotomy rate in both remifentanil and dexmedetomidine group
Time frame: Up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Results publication: PubMed 33209418Hao GW, Luo JC, Xue Y, Ma GG, Su Y, Hou JY, Yu SJ, Liu K, Zheng JL, Tu GW, Luo Z. Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study. J Thorac Dis. 2020 Oct;12(10):5857-5868. doi: 10.21037/jtd-20-1678.
- Derived from this study: PubMed 39294818Hao GW, Wu JQ, Yu SJ, Liu K, Xue Y, Gong Q, Xie RC, Ma GG, Su Y, Hou JY, Zhang YJ, Liu WJ, Li W, Tu GW, Luo Z. Remifentanil vs. dexmedetomidine for cardiac surgery patients with noninvasive ventilation intolerance: a multicenter randomized controlled trial. J Intensive Care. 2024 Sep 18;12(1):35. doi: 10.1186/s40560-024-00750-2.
- Derived from this study: PubMed 37189085Deng YZ, Luo MH, Luo JC, Li JK, Chen JQ, Zhang YJ, Hou JY, Su Y, Tu GW, Luo Z. Postoperative glucocorticoids in patients with acute type A aortic dissection (GLAD): study protocol for a prospective, single-center, randomized controlled trial. BMC Anesthesiol. 2023 May 15;23(1):164. doi: 10.1186/s12871-023-02124-x.
- Derived from this study: PubMed 35345251Luo MH, Hao GW, Liu K, Yin K, Yu SJ, Wang H, Su Y, Luo JC, Wei YQ, Wang YH, Pan WQ, Tu GW, Luo Z. Remifentanil versus Dexmedetomidine in Cardiac Surgery Patients with Noninvasive Ventilation Intolerance: Protocol for the REDNIVI Trial. Rev Cardiovasc Med. 2022 Mar 4;23(3):84. doi: 10.31083/j.rcm2303084.
- Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort studyLink provided by the sponsor.
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.
Zhe Luo, MD PhD study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil and Dexmedetomidine in people with NIV Intolerance, run by Shanghai Zhongshan Hospital 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 3 inclusion and 14 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 16 Mar 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.
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 Guo-wei Tu, MD PhD (13501996995, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine. (time frame: Within 72 hours of study drug used). 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 NCT04734418, which also lists 4 linked publications.
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 16 Mar 2021.