Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance After Cardiac Surgery: a Multicenter, Prospective, Single-blind, Randomized Controlled Study

Conditions
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NIV Intolerance

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil group<br> | Drug: Remifentanil<br>* 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<br>|
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |