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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil group | Experimental |
| |
| Dexmedetomidine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine. | Within 72 hours of study drug used |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in both remifentanil and dexmedetomidine group | Up to 30 days | |
| Mechanical ventilation time in both remifentanil and dexmedetomidine group | Up to 30 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo-wei Tu, MD PhD | Contact | 13501996995 | tu.guowei@zs-hospital.sh.cn | |
| Guang-wei Hao, MD PhD | Contact | 15921488129 | hao.guangwei@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhe Luo, MD PhD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33209418 | Result | 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. | |
| 39294818 |
| Label | URL |
|---|---|
| Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study | View source |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Dexmedetomidine | Drug | 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. |
|
| Hemodynamic changes in both remifentanil and dexmedetomidine group |
| Up to 30 days |
| Incidence of delirium in both remifentanil and dexmedetomidine group | Up to 30 days |
| Days in ICU in both remifentanil and dexmedetomidine group | Up to 30 days |
| Intubation rate in both remifentanil and dexmedetomidine group | Up to 30 days |
| Tracheotomy rate in both remifentanil and dexmedetomidine group | Up to 30 days |
| Hao 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. |
| 37189085 | Derived | Deng 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. |
| 35345251 | Derived | Luo 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. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |