Compare the Effects of Remifentanil and Fentanyl on the Duration of Mechanical Ventilation of ICU Patients

NCT05014711 | Unknown Phase 4 DMC

• 1 other identifier: KY-2019-082-02
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

To verify whether remifentanil is more beneficial to reduce the duration of mechanical ventilation, shorten the interval from SBT to extubation, reduce the incidence of adverse events, reduce the workload of nursing staff, reduce the dosage of sedatives and ICU hospitalization costs, shorten the length of ICU hospitalization, and reduce the short-term mortality.

Conditions

Mechanical Ventilation

Keywords

mechanical ventilation; remifentanil; fentanyl; analgesia

Outcome Measures

Primary Outcomes (1)

• duration of mechanical ventilation

  from the time of enrollment to successful removal from the ventilator

  the end point of time is successfully transferred out of ICU or death or 28 days after enrollment

Secondary Outcomes (3)

• Incidences of adverse events

  1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first.

• the interval from SBT(Spontaneous Breathing Trial) to extubation

  the end point of time is successfully transferred out of ICU or death or 28 days after enrollment

• dosages and costs of analgesic and sedative drugs

  1) Tracheal intubation has been successfully removed; 2) Tracheal intubation has not been removed 15 days after inclusion, and the patient would be followed up for 15 days; 3) Tracheotomy and the ventilator successfully removed,whichever comes first.

Study Arms (2)

remifentanil group

EXPERIMENTAL

After enrollment, remifentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed.

Drug: Remifentanil

fentanil group

ACTIVE COMPARATOR

After enrollment, fentanil will be used for analgesia. Duration of mechanical ventilation, incidences of adverse events, interval from SBT to extubation, dosages and costs of analgesics and sedatives drugs will be observed.

Drug: Fentanyl

Interventions

Remifentanil DRUG

Before infusion, remifentanil is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT \< 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min.

Also known as: remifentanil hydrochloride

remifentanil group

Fentanyl DRUG

Before infusion, fentanyl is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT \< 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min.

Also known as: Fentanyl citrate

fentanil group

Eligibility Criteria

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

You may qualify if:

• (1) Oral endotracheal intubation requiring mechanical ventilation; and (2) 18-85 years old; and (3) expected to require mechanical ventilation for longer than 24 hours.

You may not qualify if:

• (1) Deep sedation is required (PaO2/FiO2 ≤100, loss of consciousness during treatment with muscle relaxants, status epilepticus, surgery or surgical conditions require absolute immobilization, severe brain injury with intracranial hypertension, therapeutic hypothermia, etc. And other clinical assessments need to maintain RASS\<-2); (2) The time of using sedatives or opioid analgesics is longer than 1 week before enrollment; (3) ICU stay ≥ 1 week before enrollment; (4) Invasive mechanical ventilation time ≥ 48 hours before enrollment; (5) According to the condition of the disease, it is estimated that mechanical ventilation will be needed for too long, such as the accumulation of respiratory muscles in peripheral neuromuscular diseases, brainstem damage and respiratory center involvement; (6) Delirium, alcohol withdrawal symptoms or mental illness or use of antipsychotic drugs; (7) Severe abnormal liver function (Child-Pugh grade C); (8) Renal insufficiency requires renal replacement therapy; (9) Surgical treatment is required during mechanical ventilation (except for minor operations, such as lumbar puncture, ventricular drainage, etc.); (10) Allergy to study drugs or other contraindications; (11) Pregnant or lactating women; (12) Has been selected for other RCT tests; (13) The patient or the legally authorized person is unwilling to participate in the trial; (14) The investigator judged that the patient was not suitable for selection (such as severe hypotension; potential disputes, etc.)

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Remifentanil; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jian-Xin Zhou, MD

  Capital Medical University

  STUDY CHAIR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

861059978019; zhoujx.cn@icloud.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)