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

An observational study of Cardiac Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Cardiac Surgery
What is being tested?: Remifentanil and Dexmedetomidine
Type of treatment: Injection or infusion
How many people: 90 participants
Where: 1 siteChina
Study dates: 1 Jan 2018to 31 Mar 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan hospital, Fudan university
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Cardiac Surgery
Being tested: Remifentanil, Dexmedetomidine
Keywords: noninvasive ventilation, remifentanil, dexmedetomidine, cardiac surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemifentanilDrug
The noninvasive ventilation intolerated patients was sedated by remifentanil.
DexmedetomidineDrug
The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.

Study groups in NCT03395886
Study group	Role	What they receive
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. Receives: Drug: 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. Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201831 Mar 2019

First posted10 Jan 2018
Study start1 Jan 2018
Primary completion31 Mar 2019
Study completion31 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03395886
Sponsor's protocol ID: REDNIVIN
Acronym: REDNIVIN
Status last verified: Aug 2019
First submitted: 21 Dec 2017
Last updated: 29 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Remifentanil Versus Dexmedetomidine for Post-Cardiac Surgery Patients With Noninvasive Ventilation Intolerance: A Prospective, Observational,Cohort Study
ClinicalTrials.gov ID: NCT03395886
Acronym / sponsor ID: REDNIVIN / REDNIVIN
Conditions: Cardiac Surgery
Keywords: noninvasive ventilation, remifentanil, dexmedetomidine, cardiac surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 31 Mar 2019 (actual)
Study completion: 31 Mar 2019 (actual)
First posted: 10 Jan 2018 (actual)
Results: Posted 29 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
remifentanil group	–	Drug: RemifentanilEligible 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	–	Drug: DexmedetomidineEligible 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RemifentanilThe noninvasive ventilation intolerated patients was sedated by remifentanil.	Drug	remifentanil group
DexmedetomidineThe noninvasive ventilation intolerated patients was sedated by dexmeditomidine.	Drug	dexmedetomidine group

Primary outcome

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

1 secondary outcome

Number of Participants With NIV Mitigation
Time frame: 72 hours after the initiation of sedation

Results and safety

Results posted to the registry on 29 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remifentanil Group	52	0
Dexmedetomidine Group	38	0

Primary outcome: Number of Participants With NIV Failure

Time frame: 72 hours after the initiation of sedation. Count of participants. Unit: Participants

Measure	Remifentanil Group n = 52	Dexmedetomidine Group n = 38
Value	10	8

Remifentanil Group vs Dexmedetomidine Group: p = 0.831, Chi-squared

Population analysed: Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 72 hours after the initiation of sedation regime. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remifentanil Group	0 of 52 (0%)	0 of 52 (0%)	6 of 52
Dexmedetomidine Group	0 of 38 (0%)	0 of 38 (0%)	4 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guo-wei Tu, PhD principal investigator

Fudan University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With NIV Failure (time frame: 72 hours after the initiation of sedation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03395886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.