Clinical trial NCT06479655: Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
Official title: Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Effect of Drug
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial, two arms
Primary purpose: SUPPORTIVE_CARE

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. 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.

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

Primary outcomes:
measure: RASS score at 12 and 24 hours
timeFrame: 24 hours from study drug initiation
measure: Rescue sedation doses
timeFrame: 24 hours from study drug initiation
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 90 Days
measure: Length of ICU stay
timeFrame: 90 days
measure: 14 days mortality rate
timeFrame: 14 days from randomization
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Mohd Zulfakar Mazlan, MBBS
state: Kelantan
Study officials:
References: