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

Not Applicable

• Conditions: NIV Intolerance
• Interventions: Drug: Remifentanil; Drug: Dexmedetomidine

• Registration Number: NCT04734418
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-02-02
• Status Verified: 2021-03
• Study Start: 2021-03-08
• Last Update Submitted: 2021-03-14
• Last Update Posted: 2021-03-16
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil group	Remifentanil	-
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Days in ICU in both remifentanil and dexmedetomidine group	Up to 30 days
Incidence of delirium in both remifentanil and dexmedetomidine group	Up to 30 days
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
Intubation rate in both remifentanil and dexmedetomidine group	Up to 30 days
Tracheotomy rate in both remifentanil and dexmedetomidine group	Up to 30 days

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China