Adult subjects admitted to the ICU clinically indicated to require sedation with propofol and invasive ventilation
Conditions
Interventions
Trade Name: Isofluran-Piramal
Product Name: Isofluran
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: ISOFLURANE
CAS Number: 26675-46-7
Concentration unit: % (V/V) percent volume/v
Sponsors
Sedana Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, >= 18 years 2. Continuous invasive ventilation and sedation = 24 hours at randomisation 4. Ongoing sedation with propofol at time of randomisation 5. Prescribed target sedation depth within the RASS range -1 to -4 6. Signed informed consent or emergency situation inclusion criteria fulfilled and documented, according to procedure described in section 9.4 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 465 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: 1. Has not reached prescribed target sedation depth any time within the last 8 hours at randomisation 2. History of or genetic predisposal for malignant hyperthermia 3. Uncompensated acute circulatory failure at time of randomisation (MAP < 55 mmHg despite iv fluids and vasopressors). 4. Hepatic impairment of classification C according to the Child-Pugh score (Cholongitas et al., 2005). 5. Any for the study relevant clinically significant abnormalities in clinical chemistry or haematology results at the time of screening , precluding study participation as judged by the investigator 6. Acute neuropathology without ICP monitoring, including but not limited to stroke, neurosurgery and head trauma. 7. Planned anaesthesia or surgery within 24 hours from randomisation 8. Tidal volume < 350 ml 9. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study 10. Need for continuous muscle relaxation at the time of randomisation 11. Positive pregnancy test in women 12. History of allergy/hypersensitivity to isoflurane or propofol 13. Known participation in any other clinical study that included drug treatment within three months of the first administration of investigational product 14. Documented limitation of medical treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that sedation with isoflurane is non-inferior to propofol in terms of maintaining adequate sedation without rescue sedation.;Secondary Objective: Evaluate the safety profile of isoflurane compared to propofol in terms of experienced adverse events, biochemistry laboratory values, vital signs and organ function. Evaluate ability to breathe spontaneous and applied ventilator mode in subjects sedated with isoflurane compared to propofol. Efficacy objectives: Evaluate wake-up time during daily sedation stops in the ICU for subjects sedated with isoflurane compared to propofol. Evaluate use of analgesic agent and behavioural pain scale assessments (BPS) in subjects sedated with isoflurane compared to propofol. Evaluate time with invasive ventilation and days in ICU in the 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol Evaluate the time to extubation for subjects sedated with isoflurane compared to propofol. ;Primary end point(s): Percentage of time when adequate sedation depth is maintained without rescue sedation with isoflurane compared to propofol as assessed according to RASS.;Timepoint(s) of evaluation of this end point: every 2 hrs from start of study medication is given until end of trial at max. 48hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints Adverse events in terms of frequency and severity for subjects sedated with isoflurane compared to propofol. Changes in vital signs, clinical chemistry and haematology values over time for subjects sedated with isoflurane compared to propofol. Difference in ability to breathe spontaneously assessed as applied ventilator mode and spontaneous breathing trial (SBT) for subjects sedated with isoflurane compared to propofol. Changes in organ failure measured by Sequential Organ Failure Assessment (SOFA) from baseline and over time during the study, up to one week after end of study sedation for subjects sedated with isoflurane compared to propofol. Changes in organ functions seven and 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol. Efficacy endpoints: Mean wake-up time for subjects sedated with isoflurane compared to propofol. Safety Endpoint: Dosing of opiates and BPS assessments in subjects sedated with isoflurane compared to propofol. Ventilator time and ventilator-free days in the 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol. ICU length of stay and ICU-free days in the 30 days after end of study sedation for subjects sedated with isoflurane compared to propofol. Time to extubation of subjects being extubated during study for subjects sedated with isoflurane compared to propofol. ;Timepoint(s) of evaluation of this end point: From start of study sedation up to study end ie at the latest 48 hours. For adverse events it is up to after end of study sedation. | — |
Countries
Germany, Slovenia
Contacts
Public ContactDr. Anke Schneider
Venn Life Sciences GmbH
Outcome results
None listed