Clinical trial

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

Name
USM/JEPeM/KK/24010062
Description
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?
Trial arms
Trial start
2024-07-15
Estimated PCD
2025-06-15
Trial end
2025-09-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Fentanyl
Intravenous fentanyl infusion with dilution of 10mcg/ml
Arms:
Fentanyl
Morphine
Intravenous morphine infusion with dilution 1mg/ml
Arms:
Morphine
Size
116
Primary endpoint
RASS score at 12 and 24 hours
24 hours from study drug initiation
Rescue sedation doses
24 hours from study drug initiation
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial, two arms', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 116, 'type': 'ESTIMATED'}}
Updated at
2024-06-28

1 organization

1 product

1 drug

1 indication

Indication
Drug Effect
Product
Morphine