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

Cardiac Surgery Clinical Trial

— REDNIVIN  

Official title:

Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance: A Prospective, Observational,Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395886
• Other study ID #: REDNIVIN
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2019
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Remifentanil
The noninvasive ventilation intolerated patients was sedated by remifentanil.
• Dexmedetomidine
The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With NIV Failure	NIV failure was defined by reintubation or death in the course of this study	72 hours after the initiation of sedation
Secondary	Number of Participants With NIV Mitigation	Mitigation was defined by patients who were relieved from the initial intolerant status	72 hours after the initiation of sedation