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

NCT03395886 | Completed Results DMC FDA Drug

• 1 other identifier: REDNIVIN
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

noninvasive ventilation; remifentanil; dexmedetomidine; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With NIV Mitigation

  72 hours after the initiation of sedation

Study Arms (2)

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

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

Interventions

Remifentanil DRUG

The noninvasive ventilation intolerated patients was sedated by remifentanil.

remifentanil group

Dexmedetomidine DRUG

The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.

dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Interventions

Remifentanil; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Results Point of Contact

• Title: Mr Zhe Luo
• Organization: Zhongshan Hospital, Fundan university

ec@zs-hospital.sh.cn

64041990

Study Officials

• Guo-wei Tu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 10, 2018
• Study Start: January 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: November 29, 2019
• Results First Posted: November 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)