NCT04734418

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

January 22, 2021

Last Update Submit

March 14, 2021

Conditions

NIV Intolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Remifentanil group

EXPERIMENTAL
Drug: Remifentanil

Dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Interventions

RemifentanilDRUG

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

Remifentanil group
DexmedetomidineDRUG

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.

Dexmedetomidine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 33209418RESULT

  • Hao GW, Wu JQ, Yu SJ, Liu K, Xue Y, Gong Q, Xie RC, Ma GG, Su Y, Hou JY, Zhang YJ, Liu WJ, Li W, Tu GW, Luo Z. Remifentanil vs. dexmedetomidine for cardiac surgery patients with noninvasive ventilation intolerance: a multicenter randomized controlled trial. J Intensive Care. 2024 Sep 18;12(1):35. doi: 10.1186/s40560-024-00750-2.

    PMID: 39294818DERIVED

  • Deng YZ, Luo MH, Luo JC, Li JK, Chen JQ, Zhang YJ, Hou JY, Su Y, Tu GW, Luo Z. Postoperative glucocorticoids in patients with acute type A aortic dissection (GLAD): study protocol for a prospective, single-center, randomized controlled trial. BMC Anesthesiol. 2023 May 15;23(1):164. doi: 10.1186/s12871-023-02124-x.

    PMID: 37189085DERIVED

  • 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.

    PMID: 35345251DERIVED

Related Links

MeSH Terms

Interventions

RemifentanilDexmedetomidine

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Study Officials

  • Zhe Luo, MD PhD

    Fudan University

    STUDY CHAIR

Central Study Contacts

Guo-wei Tu, MD PhD

CONTACT

13501996995tu.guowei@zs-hospital.sh.cn

Guang-wei Hao, MD PhD

CONTACT

15921488129hao.guangwei@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 2, 2021

Study Start

March 8, 2021

Primary Completion

January 31, 2023

Study Completion

February 28, 2023

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

CN(1)