Actively Recruiting
Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
Led by Universiti Sains Malaysia · Updated on 2025-10-06
116
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness of fentanyl versus morphine as analgosedation in adult patients who are mechanically ventilated in the intensive care unit (ICU). The study aims to determine which sedation method better achieves targeted sedation scores at 12 and 24 hours and to compare the need for rescue sedation doses between the two groups. Additional outcomes include duration of mechanical ventilation, length of ICU stay, and 14-day mortality rate. Participants will be randomly assigned to receive either intravenous fentanyl infusion at a dose of 0.5 to 1 mcg/kg/hr or intravenous morphine infusion at 0.05 to 0.1 mg/kg/hr for sedation. The study drugs will be started according to group assignment, and sedation will be continuously infused while patients remain mechanically ventilated in the ICU. During the study, researchers will monitor sedation scores using the Richmond Agitation-Sedation Scale (RASS) at 12 and 24 hours after drug initiation. They will also record the need for rescue sedation doses within 24 hours. Secondary outcomes such as mechanical ventilation duration and ICU length of stay will be followed for up to 90 days, and mortality will be assessed at 14 days. The total participation duration will vary based on patient condition and ICU stay length.
CONDITIONS
Brief Title
Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years old
- Patients expected to require invasive mechanical ventilation in ICU for more than 24 hours
- Patients for whom continuous infusion of sedation is decided by ICU team
- Patients ventilated and sedated not more than 12 hours before ICU admission
You will not qualify if you...
- 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 allergic to morphine or fentanyl
- Patients receiving neuromuscular blockers
- Patients who are pregnant
- Patients diagnosed with severe traumatic brain injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours from study drug initiation
Participants receive intravenous fentanyl or morphine infusion for sedation while mechanically ventilated in the ICU.
Continuous infusion with sedation assessments at 12 and 24 hours
Duration - Up to 90 days
Participants are monitored for duration of mechanical ventilation, length of ICU stay, and mortality up to 90 days after treatment.
Assessments during ICU stay and mortality follow-up up to 14 days
Trial Site Locations
Total: 1 location
1
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia, 16150
Actively Recruiting
Research Team
M
Mohd Zulfakar Mazlan Dr, MBBS
S
Saravana Raj Joseph, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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