Ketamine Efficacy for Acute Severe Bronchospasm in Mechanically Ventilated-critically Ill Patients: a Randomized Controlled Trial
| Registry | NCT03000413, acronym MACANUDO |
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| Status | Completed |
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| Phase | Phase 2 / Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 45 (Actual) |
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| Sponsor | Hospital Nossa Senhora da Conceicao (Other) |
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| Conditions | Critical Illness, Asthma, Bronchospasm |
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| Interventions | Ketamine, Fentanyl (Drug) |
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| Dates | start 2015-06-04, primary completion 2017-06-16, completion 2018-01-29, first posted 2016-12-22, last updated 2024-05-21 |
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| Locations | 1 site in Brazil |
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-Summary
Despite few scientific evidence that could support the use of ketamine in adult patients undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely employed in this setting. The aim of this study is therefore assess more definitively the real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and need for MV in order to establish or refute the use of this drug as "standard therapy" in these cases.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Ketamine | Experimental | Drug: Ketamine | Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h) |
| Fentanyl | Active comparator | Drug: Fentanyl | Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h) |
- Ketamine (Drug): Active treatment
- Fentanyl (Drug)
+Outcome measures
Primary outcomes
- bronchospasm improvement [3 hours post beginning of drug infusion]: Maximal airway resistance reduction in hour 3-post beginning of drug infusion
Secondary outcomes
- bronchospasm improvement [24 hours post beginning of drug infusion]: Maximal airway resistance reduction in 24th hour post beginning of drug infusion
- Time to weaning [Time (in days) to first spontaneous breathing trial post randomization up to 28 days]: Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Other outcomes
- Dynamic complacence improvement [3 hours and 24 hours post beginning of drug infusion]
- Air trapping improvement [3 hours and 24 hours post beginning of drug infusion]: intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion
- Heart rate [3 hours and 24 hours post beginning of drug infusion]: Heart rate in 3 hours and 24h post beginning of drug infusion
- Blood pressure [3 hours and 24 hours post beginning of drug infusion]: Blood pressure variation in 3 hours and 24hours post beginning of drug infusion
+Eligibility
Sex: Male, ages: 18 Years to any
Inclusion Criteria:
* patients with acute exacerbation of COPD or status asthmaticus, undergoing controlled mechanical ventilation
* acute bronchospasm, defined as airway resistance value (Rsr max) greater than 12, use of inhaled therapy with bronchodilators and systemic corticosteroids
* patients requiring the use of continuous intravenous sedation for optimization of ventilation
Exclusion Criteria:
* contraindication or history of previous adverse events with the use of the studied drugs
* other diagnostic potential Rsr increase of not causing bronchospasm (bronchial obstruction, acute respiratory distress syndrome adult, pulmonary fibrosis)
+Locations (1)
| Facility | City | Country | Status |
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| Hospital Nossa Senhora da Conceição | Porto Alegre | Brazil | |
+Publications
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