Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance

Completed

Conditions: Cardiac Surgery

Interventions: Drug: Remifentanil
Drug: Dexmedetomidine

Registration Number: NCT03395886

Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary: The aim of this study is to compare the sedation effects between remifentanil and dexmedetomidine in post-cardiac surgical patients who developed noninvasive ventilation (NIV) intolerance.

Detailed Description: This study is a prospective,observational,cohort study. Data of post-cardiac surgical patients who receives noninvasive ventilation (NIV) in the investigators' cardiac surgical intensive care unit are prospectively collected into a database for further analyzation since January 2018. Tolerance of NIV is estimated by a four-point NIV intolerance score system: A score of 1 indicates a comfortable and relaxed patient tolerating NIV; a score of 2 indicates mild intolerance with some discomfort and occasional grabbing at the NIV mask; a score of 3 indicates moderate intolerance and discomfort with the NIV mask most of the time with frequent grabbing at the mask (sometimes pulling it off); and a score of 4 indicates severe NIV intolerance with agitation or/and an inability to leave the NIV mask in place. Participants who receives re-intubation will be recorded as 4 points. Application of remifentanil or dexmedetomidine will be initiated when a score of 3 or 4 was recorded, according to the intensivists' preference.Depending on the sedation regime applied, patients with NIV intolerance are divided into two groups: remifentanil group and dexmedetomidine group.The investigators will compare the two groups with the NIV intolerance score at 15min,1, 3, 6, 12, 24, 48, 60 and 72 hours after the initiation of the sedation regime. The investigators will also compare the two groups with clinical outcomes such as NIV failure, tracheotomy rate, mortality, ICU length of stay etc.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

Inclusion Criteria

adult patients
after cardiac surgery
receiving noninvasive ventilation
moderate to severe NIV intolerance (NIV intolerance score of 3 or 4)

Exclusion Criteria

difficult expectoration
pregnancy or breastfeeding
intensive care delirium screening checklist score more than 4
drug abuse history
known allergy to opiods
cardiogenic shock
malignant arrhythmias

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
remifentanil group	Remifentanil	Eligible patients will receive a continuous infusion of remifentanil starting with 0.05 μg/kg/min. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 0.12 μg/kg/min.
dexmedetomidine group	Dexmedetomidine	Eligible patients will receive a continuous infusion of dexmiditomidine starting with 0.5 μg/kg/h. The doses will be adjusted according to the sedation satisfaction (sedation target is to achieve NIV-intolerance score 1-2), and the maximum dose is 1 μg/kg/h.

Primary Outcome Measures

Name	Time	Method
Number of Participants With NIV Failure	72 hours after the initiation of sedation	NIV failure was defined by reintubation or death in the course of this study

Secondary Outcome Measures

Name	Time	Method
Number of Participants With NIV Mitigation	72 hours after the initiation of sedation	Mitigation was defined by patients who were relieved from the initial intolerant status