Phase 3
N=94
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
Sedation
Bottom Line
View on ClinicalTrials.gov: NCT04684238 ↗Enrolled (actual)
94
Serious AEs
28.7%
Results posted
May 2025
Primary outcome: Primary: Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) — 62.37; 68.94 Percentage of time
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Midazolam (Drug); Isoflurane (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Sedana Medical
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) |
65.57; 70.91 | — |
| SECONDARY Compare the Use of Opioids |
0.58; -0.19 | 0.096 |
| SECONDARY Compare the Use of Opioids |
0.58; -0.19 | 0.096 |
| SECONDARY Compare Time From End of Study Drug Administration to Extubation |
1.09; 0.75 | 0.0021 sig |
| SECONDARY Compare the Proportion of Time With Spontaneous Breathing |
0.44; 0.48 | 0.636 |
| SECONDARY Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent |
5.4; 3.4; 1.9; 8.8 | 0.55 |
| SECONDARY Evaluate the Number of Patients With Withdrawal Symptom |
2; 3 | — |
| SECONDARY Evaluate the Frequency of Delirium |
5; 12 | — |
| SECONDARY Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction |
6; 16 | — |
| SECONDARY Compare the 30 Days/Hospital Mortality |
2; 0 | — |
| SECONDARY Compare Ventilator-free Days |
22.55; 25.00 | — |
| SECONDARY Compare the Time in ICU/Hospital |
10.21; 9.65 | — |
| SECONDARY Compare ICU-free Days |
18.58; 20.35 | — |
Summary
This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device (ACD)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.
Eligibility Criteria
Inclusion Criteria
- Patients at least 3 years to 17 (less than 18) years at the time of randomization, admitted to an ICU/with planned ICU admission.
- Expected mechanical (invasive) ventilation and sedation for at least 12 hours.
- Informed consent obtained from the patient, patient's legal guardian(s)
Exclusion Criteria
- Ongoing seizures requiring acute treatment.
- Continuous sedation for more than 72 hours at time of randomization.
- Less than 24 hours post cardiopulmonary resuscitation.
- Uncompensated circulatory shock.
- Known or suspected genetic susceptibility to malignant hyperthermia.
- Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion.
- Patient with tidal volume below 30 mL or above 800 mL.
- Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator
- Patients with intracranial pressure (ICP) monitoring or with suspected increase in ICP
- Patients with treatment-induced whole-body hypothermia.
- Patients with pheochromocytoma.
- Patients with prolonged QT interval or with significant risk for prolonged QT interval.
- Patient not expected to survive next 48 hours or not committed to full medical care.
Data sourced from ClinicalTrials.gov (NCT04684238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.