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Completed

NCT Number: NCT03395886

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

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

The noninvasive ventilation intolerated patients was sedated by remifentanil.

Dexmedetomidine

Drug

The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.

Primary outcomes

  1. Number of Participants With NIV Failure

    Time frame: 72 hours after the initiation of sedation

    NIV failure was defined by reintubation or death in the course of this study

Secondary outcomes

  1. Number of Participants With NIV Mitigation

    Time frame: 72 hours after the initiation of sedation

    Mitigation was defined by patients who were relieved from the initial intolerant status

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Acronym: REDNIVIN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2018
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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