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

NCT ID: NCT05014711

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-03-31

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.

Detailed Description

Opioids are widely used for analgesia in the ICU, of which, fentanyl and remifentanil are the most commonly used. Compared with the two analgesics, fentanyl is relatively cheap, but it is metabolised by liver. Long-term infusion makes its half-life extended, and side effects increase significantly. Respiratory depression is the most serious side effect and may lead to re-intubation and even sudden death.

Remifentanil is a strong selective μ-opioid receptor agonist, rapidly metabolized by non-specific plasma and tissue esterases into inactive metabolites; it has very short context-sensitive half-life even after prolonged infusion or in patients with organ failure. Remifentanil is easy to titrate and provides excellent analgesia: it allows higher doses administration than are normally used with traditional opioids without concerns about accumulation or delayed recovery.

This feature is helpful for patients with mechanical ventilation to weaning and extubate early. Previous studies comparing the two drugs mainly focus on short-term postoperative application, and theoretically long-term use can better reflect the pharmacokinetic advantages of Remifentanil. So we designed this study.

Conditions

Mechanical Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

remifentanil group

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.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: 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.

fentanil group

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.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: 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.

Interventions

Remifentanil

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.

Intervention Type: DRUG

Fentanyl

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.

Intervention Type: DRUG

Other Intervention Names

remifentanil hydrochloride; Fentanyl citrate

Eligibility Criteria

Inclusion Criteria

• (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.

Exclusion Criteria

• (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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-Xin Zhou, MD

Role: STUDY_CHAIR

Capital Medical University

Locations

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian-Xin Zhou, MD

Role: CONTACT

zhoujx.cn@icloud.com

861059978019

Facility Contacts

Jian-Xin Zhou, MD

Role: primary

zhoujx.cn@icloud.com

861059978019

Other Identifiers

KY-2019-082-02

Identifier Type: -

Identifier Source: org_study_id