CompletedPhase 2ACTRN12620000719932

Remi-Fent1 Study: A Comparison of Remifentanil and Fentanyl in Mechanically Ventilated Patients

Remi-Fent 1: A Feasiblity study of Remifentanil vs Fentanyl in Mechanically Ventilated Patients

Sponsor

Arvind Rajamani

Enrollment

100 participants

Start Date

Jun 2, 2020

Study Type

Interventional

Conditions

Control refractory seizures Respiratory failure - issues with oxygenation or ventilation Prevent secondary brain injury Health conditions which affect the ability of the patient to protect their airway - decreased GCS for whatever reason Need to reduce oxygen consumption and to optimise oxygen delivery - severe sepsis Health conditions which impact on patency of the airway - airway obstruction from intrinsic and extrinsic sources

Summary

The primary aim of this study is to determine the feasibility of conducting an RCT of remifentanil versus fentanyl for opioid analgesic infusion in invasively ventilated patients who are expected to require mechanical ventilation for longer than 24 hours.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

a. Patient intubated and receiving mechanical ventilation
b. Treating clinician expects that the patient will remain intubated until the day after tomorrow (unlikely to be extubated the following day)
c. Patient requires immediate ongoing opioid analgesic infusion for comfort, safety, and to facilitate the delivery of life support measures

Exclusion Criteria3

a. Patient is pregnant and/or lactating
b. Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours in an intensive care unit
c. Known sensitivity to any of the study medications or the constituents of the study medications

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Interventions

Remifentanil infusion via intravenous route will be provided for a minimum duration of 24 hours and continued until the patient no longer requires mechanical ventilation. Infusion rate will start at

Remifentanil infusion via intravenous route will be provided for a minimum duration of 24 hours and continued until the patient no longer requires mechanical ventilation. Infusion rate will start at 6-9 mcg/kg/hr and be titrated by the ICU nurse as per the target Richmond Agitation-Sedation Scale (RASS), and assessment of pain and discomfort

Locations(1)

Nepean Hospital - Kingswood

NSW, Australia

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ACTRN12620000719932