Effect of DrugPhase 4NCT06479655
Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
A Phase 4 study testing Fentanyl and Morphine in people with Effect of Drug, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Fentanyl and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Jul 2024to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
Mohd Zulfakar Mazlan, MBBS, +6097673000 ext. 6104, zulfakar@usm.my
zulfakar@usm.my
About this study
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 :
- 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)?
- Is there a difference between the proportion of patients requiring rescue sedation dose between the fentanyl and morphine groups?
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Intravenous fentanyl infusion with dilution of 10mcg/ml
MorphineDrug
Intravenous morphine infusion with dilution 1mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Active comparator | Intravenous fentanyl infusion 0.5 - 1 mcg/kg/hr Receives: Drug: Fentanyl |
| Morphine | Active comparator | Intraveous morphine infusion 0.05 - 0.1 mg/kg/hr Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
RASS score at 12 and 24 hours
To determine the proportion of patients achieving the targeted sedation guided by RASS score at 12 and 24 hours in both fentanyl and morphine group.
Measured: 24 hours from study drug initiation
Rescue sedation doses
To determine the proportion of patients requiring rescue sedation doses between fentanyl and morphine group
Measured: 24 hours from study drug initiation
Secondary outcomes (3)
Duration of mechanical ventilation
To compare the duration of mechanical ventilation between the fentanyl and morphine groups
Measured: 90 Days
Length of ICU stay
To compare the length of ICU stay between the fentanyl and morphine groups
Measured: 90 days
14 days mortality rate
To compare 14-day mortality rates between the fentanyl and morphine groups
Measured: 14 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Jul 2024
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial, two arms
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479655
- Sponsor's protocol ID
- USM/JEPeM/KK/24010062
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy and Outcome Between Fentanyl and Morphine as Analgo-sedation in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06479655
- Acronym / sponsor ID
- USM/JEPeM/KK/24010062
- Conditions
- Effect of Drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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)?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial, two arms
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Active comparator | Drug: FentanylIntravenous fentanyl infusion 0.5 - 1 mcg/kg/hr |
| Morphine | Active comparator | Drug: MorphineIntraveous morphine infusion 0.05 - 0.1 mg/kg/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylIntravenous fentanyl infusion with dilution of 10mcg/ml | Drug | Fentanyl |
| MorphineIntravenous morphine infusion with dilution 1mg/ml | Drug | Morphine |
Primary outcome
RASS score at 12 and 24 hours
Time frame: 24 hours from study drug initiation
To determine the proportion of patients achieving the targeted sedation guided by RASS score at 12 and 24 hours in both fentanyl and morphine group.
Rescue sedation doses
Time frame: 24 hours from study drug initiation
To determine the proportion of patients requiring rescue sedation doses between fentanyl and morphine group
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Morphine in people with Effect of Drug, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohd Zulfakar Mazlan Dr, MBBS (+60135335566, zulfakar@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RASS score at 12 and 24 hours (time frame: 24 hours from study drug initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.