Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
NCT ID: NCT06479655
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
116 participants
INTERVENTIONAL
2024-07-15
2025-12-30
Brief Summary
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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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Detailed Description
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Furthemore duration of mechanical ventilation, length of ICU stay and 14 days mortality rate will recorded and compared between this 2 groups of patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Fentanyl
Intravenous fentanyl infusion 0.5 - 1 mcg/kg/hr
Fentanyl
Intravenous fentanyl infusion with dilution of 10mcg/ml
Morphine
Intraveous morphine infusion 0.05 - 0.1 mg/kg/hr
Morphine
Intravenous morphine infusion with dilution 1mg/ml
Interventions
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Fentanyl
Intravenous fentanyl infusion with dilution of 10mcg/ml
Morphine
Intravenous morphine infusion with dilution 1mg/ml
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Universiti Sains Malaysia
OTHER
Responsible Party
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Mohd Zulfakar Mazlan, MBBS
Associate Prof Dr
Locations
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Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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USM/JEPeM/KK/24010062
Identifier Type: -
Identifier Source: org_study_id
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