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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Active Comparator | Intravenous fentanyl infusion 0.5 - 1 mcg/kg/hr |
|
| Morphine | Active Comparator | Intraveous morphine infusion 0.05 - 0.1 mg/kg/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Intravenous fentanyl infusion with dilution of 10mcg/ml |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours from study drug initiation |
| Rescue sedation doses | To determine the proportion of patients requiring rescue sedation doses between fentanyl and morphine group | 24 hours from study drug initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | To compare the duration of mechanical ventilation between the fentanyl and morphine groups | 90 Days |
| Length of ICU stay | To compare the length of ICU stay between the fentanyl and morphine groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohd Zulfakar Mazlan Dr, MBBS | Contact | +60135335566 | zulfakar@usm.my | |
| Saravana Raj Joseph, MD | Contact | +6017 9570541 | ragan_23@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Recruiting | Kota Bharu | Kelantan | 16150 | Malaysia |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
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Randomized control trial, two arms
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| Morphine |
| Drug |
Intravenous morphine infusion with dilution 1mg/ml |
|
| 90 days |
| 14 days mortality rate | To compare 14-day mortality rates between the fentanyl and morphine groups | 14 days from randomization |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |