Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversiti Sains Malaysia

About this trial

The primary aim of this clinical trial is to compare the effectiveness of fentanyl vs morphine as analgosedation in mechanically ventilated adult patients in the ICU. This study also aims to compare the outcomes of patients between the two groups.

The main questions it aims to answer are :

1. Does propofol and fentanyl infusion as analgo-sedation achieve targeted sedation score at 12 and 24 hours compared to propofol and morphine infusion in mechanically ventilated adult patients in the intensive care unit (ICU)? 2. Is there a difference between the proportion of patients requiring rescue sedation dose between the fentanyl and morphine groups?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years old

Patients who are expected by the ICU team to require invasive mechanical ventilation in ICU for at least more than 24 hours and for whom the ICU team decides to initiate continuous infusion of sedation

A patient who was ventilated and sedated not more than 12 hours before ICU admission.

Disqualifiers

Patients with chronic use of narcotics

Patients with chronic liver failure or end-stage renal failure

Patients with severe chronic neurocognitive dysfunction

Patients with drug overdose

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fentanyl

    Drug

    Intravenous fentanyl infusion with dilution of 10mcg/ml

  • Morphine

    Drug

    Intravenous morphine infusion with dilution 1mg/ml

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: FentanylActive comparator 1 intervention
Group B: MorphineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

RASS score at 12 and 24 hours

To determine the proportion of patients achieving the targeted sedation guided by RASS score at 12 and 24 hours in both fentanyl and morphine group.

Time frame
24 hours from study drug initiation
2

Rescue sedation doses

To determine the proportion of patients requiring rescue sedation doses between fentanyl and morphine group

Time frame
24 hours from study drug initiation

Secondary outcomes

1

Duration of mechanical ventilation

To compare the duration of mechanical ventilation between the fentanyl and morphine groups

Time frame
90 Days
2

Length of ICU stay

To compare the length of ICU stay between the fentanyl and morphine groups

Time frame
90 days
3

14 days mortality rate

To compare 14-day mortality rates between the fentanyl and morphine groups

Time frame
14 days from randomization

Other outcomes

Sponsors and contacts

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