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?

Study Overview

• Status: Recruiting
• Conditions: Effect of Drug
• Intervention / Treatment: Drug: Fentanyl; Drug: Morphine

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohd Zulfakar Mazlan Dr, MBBS; Phone Number: +60135335566; Email: zulfakar@usm.my
• Study Contact Backup: Name: Saravana Raj Joseph, MD; Phone Number: +6017 9570541; Email: ragan_23@hotmail.com

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Recruiting
      • Hospital Universiti Sains Malaysia
      • Contact: Mohd Zulfakar Mazlan, MBBS; Phone Number: 6104 +6097673000; Email: zulfakar@usm.my
      • Contact: Email: zulfakar@usm.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl; Intravenous fentanyl infusion 0.5 - 1 mcg/kg/hr	Drug: Fentanyl; Intravenous fentanyl infusion with dilution of 10mcg/ml
Active Comparator: Morphine; Intraveous morphine infusion 0.05 - 0.1 mg/kg/hr	Drug: Morphine; Intravenous morphine infusion with dilution 1mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours from study drug initiation
Rescue sedation doses	To determine the proportion of patients requiring rescue sedation doses between fentanyl and morphine group	24 hours from study drug initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation	To compare the duration of mechanical ventilation between the fentanyl and morphine groups	90 Days
Length of ICU stay	To compare the length of ICU stay between the fentanyl and morphine groups	90 days
14 days mortality rate	To compare 14-day mortality rates between the fentanyl and morphine groups	14 days from randomization

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Morphine; Fentanyl
• Other Study ID Numbers: USM/JEPeM/KK/24010062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No