A Phase 2/3 interventional study of Ketamine and Fentanyl in Critical Illness, Asthma and Bronchospasm, sponsored by Hospital Nossa Senhora da Conceicao. Completed at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Hospital Nossa Senhora da Conceicao · Phase 2/3, Interventional, and Treatment
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 45 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Hospital Nossa Senhora da Conceicao is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Compared within Asthma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous ketamine infusion: bolus 2mg per kg and continuous infusion (2mg/kg/h)
Drug: Ketamine
Fentanyl: bolus infusion 1μg per kg and continuous infusion (1μg/kg/h)
Drug: Fentanyl
bronchospasm improvement
Maximal airway resistance reduction in hour 3-post beginning of drug infusion
Time frame: 3 hours post beginning of drug infusion
bronchospasm improvement
Maximal airway resistance reduction in 24th hour post beginning of drug infusion
Time frame: 24 hours post beginning of drug infusion
Time to weaning
Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Time frame: Time (in days) to first spontaneous breathing trial post randomization up to 28 days
Dynamic complacence improvement
Time frame: 3 hours and 24 hours post beginning of drug infusion
Air trapping improvement
intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion
Time frame: 3 hours and 24 hours post beginning of drug infusion
Heart rate
Heart rate in 3 hours and 24h post beginning of drug infusion
Time frame: 3 hours and 24 hours post beginning of drug infusion
Blood pressure
Blood pressure variation in 3 hours and 24hours post beginning of drug infusion
Time frame: 3 hours and 24 hours post beginning of drug infusion
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ketamine
Hospital Nossa Senhora da Conceicao