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NCT Number: NCT06479655

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

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?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Fentanyl

Drug

Intravenous fentanyl infusion with dilution of 10mcg/ml

Morphine

Drug

Intravenous morphine infusion with dilution 1mg/ml

Primary outcomes

  1. RASS score at 12 and 24 hours

    Time frame: 24 hours from study drug initiation

    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.

  2. Rescue sedation doses

    Time frame: 24 hours from study drug initiation

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

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: 90 Days

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

  2. Length of ICU stay

    Time frame: 90 days

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

  3. 14 days mortality rate

    Time frame: 14 days from randomization

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohd Zulfakar Mazlan Dr, MBBS

CONTACT

[email protected]

+60135335566

Saravana Raj Joseph, MD

CONTACT

[email protected]

+6017 9570541

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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