Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance

Evaluation of Remifentanil and Dexmedetomidine in Patients With Noninvasive Mechanical Ventilation Intolerance After Cardiac Surgery: a Multicenter, Prospective, Single-blind, Randomized Controlled Study

Currently, NIV(Noninvasive ventilation ) is widely used in patients with hypoxemia and atelectasis after cardiac surgery.About 15% of patients have intolerance during NIV. The main manifestation is that the patient feels uncomfortable, often breaks away from the mask, and even gradually becomes agitated, which eventually leads to the failure of non-invasive ventilation.The patient's intubation rate is as high as 44%, and the mortality rate is 34%.There are many ways to prevent or treat NIV intolerance, of which the most used is to sedate the patient. This study aims to evaluate the effects of remifentanil and dexmedetomidine in the sedation of patients with intolerance to non-invasive mechanical ventilation after cardiac surgery, and to explore the optimal plan for sedation of patients with intolerant non-invasive mechanical ventilation after cardiac surgery.

Study Overview

• Status: Recruiting
• Conditions: NIV Intolerance
• Intervention / Treatment: Drug: Remifentanil; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guo-wei Tu, MD PhD; Phone Number: 13501996995; Email: tu.guowei@zs-hospital.sh.cn
• Study Contact Backup: Name: Guang-wei Hao, MD PhD; Phone Number: 15921488129; Email: hao.guangwei@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Guo-wei Tu, Doctor; Phone Number: 86-13501996995; Email: tu.guowei@zs-hospital.sh.cn
      • Principal Investigator: Guo-wei Tu, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sign the informed consent form voluntarily and follow the plan requirements;
• Age from 18 to 75 years old (including 18 and 75 years old), regardless of gender;
• Patients who received non-invasive mechanical ventilation after cardiac surgery and were intolerant of non-invasive ventilation.

Exclusion Criteria:

• A history of allergy to any component of the study drug;
• Visual analogue scale of pain (VAS) score >4；
• Who had taken dexmedetomidine within 8 hours prior to the study;
• Who had used remifentanil within 2 hours before the study began;
• Expectoration difficulties;
• Women who are pregnant or lactating;
• Coma or uncontrollable convulsions;
• Have a history of mental illness or cognitive impairment;
• Delirium before the study began;
• Patients with severe liver dysfunction (CTP grade C);
• Patients with renal insufficiency (patients receiving renal replacement therapy);
• Preoperative left ventricular ejection fraction (LVEF) < 30%;
• History of drug and alcohol abuse;
• Other conditions that the investigator deems inappropriate for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remifentanil group	Drug: Remifentanil; Intravenous pump injection.The initial dose of remifentanil is 0.05 μg/kg/min.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of remifentanil is 0.12 μg/kg/min
Active Comparator: Dexmedetomidine	Drug: Dexmedetomidine; Intravenous pump injection.The initial dose of dexmedetomidine is 0.5 μg/kg/h.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of dexmedetomidine is 1.0 μg/kg/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Remission rate of intolerance in patients with intolerance of non-invasive mechanical ventilation after cardiac surgery after sedation with remifentanil or dexmedetomidine.	Within 72 hours of study drug used

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality in both remifentanil and dexmedetomidine group	Up to 30 days
Mechanical ventilation time in both remifentanil and dexmedetomidine group	Up to 30 days
Hemodynamic changes in both remifentanil and dexmedetomidine group	Up to 30 days
Incidence of delirium in both remifentanil and dexmedetomidine group	Up to 30 days
Days in ICU in both remifentanil and dexmedetomidine group	Up to 30 days
Intubation rate in both remifentanil and dexmedetomidine group	Up to 30 days
Tracheotomy rate in both remifentanil and dexmedetomidine group	Up to 30 days

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Zhe Luo, MD PhD, Fudan University

Publications and helpful links

General Publications

• Hao GW, Luo JC, Xue Y, Ma GG, Su Y, Hou JY, Yu SJ, Liu K, Zheng JL, Tu GW, Luo Z. Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study. J Thorac Dis. 2020 Oct;12(10):5857-5868. doi: 10.21037/jtd-20-1678.
• Luo MH, Hao GW, Liu K, Yin K, Yu SJ, Wang H, Su Y, Luo JC, Wei YQ, Wang YH, Pan WQ, Tu GW, Luo Z. Remifentanil versus Dexmedetomidine in Cardiac Surgery Patients with Noninvasive Ventilation Intolerance: Protocol for the REDNIVI Trial. Rev Cardiovasc Med. 2022 Mar 4;23(3):84. doi: 10.31083/j.rcm2303084.

Helpful Links

• Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 14, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: REDNIVI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No