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

NCT06479655 | Recruiting Phase 4

• 1 other identifier: USM/JEPeM/KK/24010062
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Is there a difference between the proportion of patients requiring rescue sedation dose between the fentanyl and morphine groups?

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Duration of mechanical ventilation

  90 Days

• Length of ICU stay

  90 days

• 14 days mortality rate

  14 days from randomization

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

Intravenous fentanyl infusion 0.5 - 1 mcg/kg/hr

Drug: Fentanyl

Morphine

ACTIVE COMPARATOR

Intraveous morphine infusion 0.05 - 0.1 mg/kg/hr

Drug: Morphine

Interventions

Fentanyl DRUG

Intravenous fentanyl infusion with dilution of 10mcg/ml

Fentanyl

Morphine DRUG

Intravenous morphine infusion with dilution 1mg/ml

Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Interventions

Fentanyl; Morphine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Mohd Zulfakar Mazlan Dr, MBBS

CONTACT

+60135335566; zulfakar@usm.my

Saravana Raj Joseph, MD

CONTACT

+6017 9570541; ragan_23@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof Dr

Model Details: Randomized control trial, two arms

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 28, 2024
• Study Start: July 15, 2024
• Primary Completion: November 15, 2025
• Study Completion: December 30, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)