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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395886
Recruitment Status : Completed
First Posted : January 10, 2018
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cardiac Surgery Drug: Remifentanil Drug: Dexmedetomidine

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance: A Prospective, Observational,Cohort Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
remifentanil group
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.
Drug: Remifentanil
The noninvasive ventilation intolerated patients was sedated by remifentanil.

dexmedetomidine group
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.
Drug: Dexmedetomidine
The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult cardiac surgical patients who receive NIV and develop moderate to severe intolerance (NIV intolerance score of 3 or 4) between January 2018 and December 2019 in our CSICU will be enrolled in this study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395886


Locations
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China, Shanghai
Zhongshan hospital, Fudan university
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Guo-wei Tu, PhD Fudan University
  Study Documents (Full-Text)

Documents provided by Shanghai Zhongshan Hospital:
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03395886    
Other Study ID Numbers: REDNIVIN
First Posted: January 10, 2018    Key Record Dates
Results First Posted: November 29, 2019
Last Update Posted: November 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shanghai Zhongshan Hospital:
noninvasive ventilation
remifentanil
dexmedetomidine
cardiac surgery
Additional relevant MeSH terms:
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Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics