NCT06479655

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Effect of Drug

Interventions

Type	Name	Description
DRUG	Fentanyl	Intravenous fentanyl infusion with dilution of 10mcg/ml
DRUG	Morphine	Intravenous morphine infusion with dilution 1mg/ml

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-11-15
• Completion: 2025-12-30
• First posted: 2024-06-28
• Last updated: 2025-10-06

Locations

1 site across 1 country: Malaysia