Clinical trial NCT04734418: Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NIV Intolerance
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine.
timeFrame: Within 72 hours of study drug used
Secondary outcomes:
measure: Mortality in both remifentanil and dexmedetomidine group
timeFrame: Up to 30 days
measure: Mechanical ventilation time in both remifentanil and dexmedetomidine group
timeFrame: Up to 30 days
measure: Hemodynamic changes in both remifentanil and dexmedetomidine group
timeFrame: Up to 30 days
measure: Incidence of delirium in both remifentanil and dexmedetomidine group
timeFrame: Up to 30 days
measure: Days in ICU in both remifentanil and dexmedetomidine group
timeFrame: Up to 30 days
measure: Intubation rate in both remifentanil and dexmedetomidine group
timeFrame: Up to 30 days
measure: Tracheotomy rate in both remifentanil and dexmedetomidine group
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhe Luo, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.