Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Hospital Nossa Senhora da Conceicao

Status and phase: Completed; Phase 3; Phase 2

Conditions: Asthma; Critical Illness; Bronchospasm

Treatments: Drug: Fentanyl; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03000413

42324015.0.0000.5530

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Ketamine

Experimental group

Description:

Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)

Treatment:

Drug: Ketamine

Fentanyl

Active Comparator group

Description:

Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h)

Treatment:

Drug: Fentanyl