IMR Press / RCM / Volume 23 / Issue 3 / DOI: 10.31083/j.rcm2303084
Open Access Original Research
Remifentanil versus Dexmedetomidine in Cardiac Surgery Patients with Noninvasive Ventilation Intolerance: Protocol for the REDNIVI Trial
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1 Shanghai Medical College, Fudan University, 200032 Shanghai, China
2 Department of Critical Care Medicine, Zhongshan Hospital, Fudan University, 200032 Shanghai, China
3 Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA
4 Department of Critical Care Medicine, Xiamen Branch, Zhongshan Hospital, Fudan University, 361015 Xiamen, Fujian, China
*Correspondence: tu.guowei@zs-hospital.sh.cn (Guo-wei Tu); luo.zhe@zs-hospital.sh.cn (Zhe Luo)
These authors contributed equally.
Academic Editors: Brian Tomlinson and Takatoshi Kasai
Rev. Cardiovasc. Med. 2022, 23(3), 84; https://doi.org/10.31083/j.rcm2303084
Submitted: 28 November 2021 | Revised: 10 February 2022 | Accepted: 11 February 2022 | Published: 4 March 2022
(This article belongs to the Special Issue State-of-the-Art Cardiovascular Medicine in Asia 2021)
Copyright: © 2022 The Author(s). Published by IMR Press.
This is an open access article under the CC BY 4.0 license.
Abstract

Background: Respiratory failure is one of the most common complications following cardiac surgery. Although noninvasive ventilation (NIV) has been an effective treatment, it has a high rate of intolerance. Both remifentanil and dexmedetomidine are used as sedatives in cardiac surgery (CS) patients with NIV intolerance. However, no randomized controlled trials have compared the effects of these drugs in relieving the intolerance. Methods: REDNIVI will be a multicenter, prospective, single-blind, randomized controlled trial carried out in six clinical sites in China. Subjects with NIV intolerance will be randomized to receive remifentanil or dexmedetomidine in a ratio of 1:1. Primary outcomes of intolerance remission rate at different timings (15 minutes, 1, 3, 6, 12, 24, 36, 48, 60, 72 hours after initiation of treatment) and 72 h average remission rate will be determined. In addition, secondary outcomes such as mortality, duration of intensive care unit (ICU) stay, duration of mechanical ventilation (MV), the need for endotracheal intubation, hemodynamic changes, and delirium incidence will also be determined. Conclusions: This trial will provide evidence to determine the effects of remifentanil and dexmedetomidine in patients with NIV intolerance after cardiac surgery. Clinical Trial Registration: This study has been registered on ClinicalTrials.gov (NCT04734418).

Keywords
remifentanil
dexmedetomidine
noninvasive mechanical ventilation
ventilation intolerance
cardiac surgery
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