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

NCT ID: NCT06479655

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Effect of Drug

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial, two arms
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fentanyl

Intravenous fentanyl infusion 0.5 - 1 mcg/kg/hr

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Intravenous fentanyl infusion with dilution of 10mcg/ml

Morphine

Intraveous morphine infusion 0.05 - 0.1 mg/kg/hr

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Intravenous morphine infusion with dilution 1mg/ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fentanyl

Intravenous fentanyl infusion with dilution of 10mcg/ml

Intervention Type DRUG

Morphine

Intravenous morphine infusion with dilution 1mg/ml

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiti Sains Malaysia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohd Zulfakar Mazlan, MBBS

Associate Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohd Zulfakar Mazlan Dr, MBBS

Role: CONTACT

+60135335566

Saravana Raj Joseph, MD

Role: CONTACT

+6017 9570541

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohd Zulfakar Mazlan, MBBS

Role: primary

+6097673000 ext. 6104

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

USM/JEPeM/KK/24010062

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ketamine Versus Propofol as ICU Sedation
NCT06243822 COMPLETED PHASE4
Comparison of Sevoflurane and Propofol on ANI
NCT06907823 NOT_YET_RECRUITING NA