Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fentanyl, Morphine.
- Who it may be relevant to
- Registry conditions: Effect of Drug. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
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.
Interventions
- Drug Fentanyl
Intravenous fentanyl infusion with dilution of 10mcg/ml - Drug Morphine
Intravenous morphine infusion with dilution 1mg/ml
Primary outcome measures
- RASS score at 12 and 24 hours [Time frame: 24 hours from study drug initiation]
- Rescue sedation doses [Time frame: 24 hours from study drug initiation]
Secondary outcome measures (3)
- Duration of mechanical ventilation [Time frame: 90 Days]
- Length of ICU stay [Time frame: 90 days]
- 14 days mortality rate [Time frame: 14 days from randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Malaysia · 1 center
- Hospital Universiti Sains Malaysia — Kota Bharu
Identifiers
NCT: NCT06479655 · USM/JEPeM/KK/24010062