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

Phase 2

Recruiting

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

• Registration Number: ACTRN12620000719932
• Lead Sponsor: Arvind Rajamani

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-02
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients recruited<br>- assessed by tallying the number of patients recruited within the planned period. This will be calculated from the enrollment log in the study database[Planned recruitment period is 12-18 months post recruitment commencement];Compliance of use of the study drug >90%<br>- patient medical records detailing the drugs given to the patient for sedation and ETT tolerance<br>- patient medical records to determine the number of patients who were prematurely ceased on the study protocol [28 days post intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Quality of life at 6 months using the EQ-5D-5L questionnaire. This will be conducted by email or post or over the phone, depending on the patient's preference. [180 days post intervention commencement];To measure the cost of administering for the study medications in the 2 groups. This is estimated from the cumulative cost per patient multiplied by total number of patients in each group/[Cumulative dose of the opioid is calculated for each patient when the patient gets extubated.]