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

Last updated: September 30, 2025
Sponsor: Universiti Sains Malaysia
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Fentanyl

Morphine

Clinical Study ID

NCT06479655
USM/JEPeM/KK/24010062
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Age >18 years old

  • Patients who are expected by the ICU team to require invasive mechanical ventilationin ICU for at least more than 24 hours and for whom the ICU team decides to initiatecontinuous infusion of sedation

  • A patient who was ventilated and sedated not more than 12 hours before ICUadmission.

Exclusion

Exclusion Criteria:

  • 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

  • Patients with a known allergy to either morphine or fentanyl

  • Patients who are receiving neuromuscular blockers

  • Patients who are pregnant

  • Patients who are diagnosed to have severe traumatic brain in

Study Design

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: Fentanyl
Phase: 4
Study Start date:
July 15, 2024
Estimated Completion Date:
December 30, 2025

Study Description

Researchers will randomize patients into 2 groups (Fentanyl and Morphine) and will start study drug accordingly for sedation in ICU.Proportion of patients from each group achieving targeted sedation score at 12 and 24 hours following initiation of the drug and proportion of patients from each group requiring rescue sedation dose will be recorded and analyzed.

Furthemore duration of mechanical ventilation, length of ICU stay and 14 days mortality rate will recorded and compared between this 2 groups of patients.

Connect with a study center

  • Mohd Zulfakar Mazlan, MBBS

    Kota Bharu, Kelantan 16150
    Malaysia

    Site Not Available

  • Hospital Universiti Sains Malaysia

    Kota Bharu 1736376, Kelantan 1733044 16150
    Malaysia

    Active - Recruiting

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