Trial · NCT05327296
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)
NCT05327296, Phase 3, Completed, Sedana Medical; results first posted 2026-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2). Trials, record NCT05327296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05327296
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)
- NCT number
- NCT05327296
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 282 participants, actual
- Lead sponsor
- Sedana Medical
- Conditions
- Sedation
- Interventions
- Isoflurane, Propofol
- First posted
- 2022-04-14
- Last updated
- 2026-03-24
- Results first posted
- 2026-03-03
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients | From start to end of study treatment (up to 48 (±6) hours) | The Target Range is RASS -1 to -4. The Richmond Agitation-Sedation Scale (RASS) is used to measure the level of agitation or sedation in patients, particularly in critical care settings. It is a 10-point scale ranging from -5 to +4: +4 Combative - Violent, immediate danger to staff. +3 Very agitated - Pulls or removes tubes or catheters; aggressive. +2 Agitated - Frequent non-purposeful movement, fights ventilator. +1 Restless - Anxious but movements are not aggressive. 0 Alert and calm. -1 Drowsy - Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice for more than 10 seconds. -2 Light sedation - Briefly awakens with eye contact to voice for less than 10 seconds. -3 Moderate sedation - Movement or eye opening to voice, but no eye contact. -4 Deep sedation - No response to voice, but movement or eye opening to physical stimulation. -5 Unarousable - No response to voice or physical stimulation. |
| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period | From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours) | To compare the effect of isoflurane vs propofol on use of opioids during the study treatment period by measuring change in mean fentanyl-equivalent opioid dose during the study treatment period compared to mean opioid dose during the 60 minutes prior to baseline. |
| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment | Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours) | |
| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours) | Cognitive recovery will be assessed by the 7-point scale of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7) at 60 (±10) minutes after end of study drug treatment in patients not re-sedated with benzodiazepine or propofol infusions. The scale ranges from 0 to 7, with higher scores indicating more severe delirium |
| Secondary | Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period | From start to end of study treatment, up to 48 (±6) hours | Proportion of ventilator parameter observations with spontaneous breathing efforts during the study drug treatment period |
| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation | From end of study drug treatment to extubation (up to 7 Days after randomization) | |
| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30 | From start of study treatment up to 30 days | |
| Secondary | Other Secondary: To Compare the Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU | From start of study treatment up to 30 days | |
| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment | From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation) | |
| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization | At 30 days after randomization | Participants reported represent participants that died between randomization and 30 days in the Safety population |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients | From start to end of study treatment (up to 48 (±6) hours) | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | percentage of time | MEAN |
| SECONDARY | Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period | From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours) | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | µg/kg/hr fentanyl equivalents | MEAN |
| SECONDARY | Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment | Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours) | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | minutes | MEDIAN |
| SECONDARY | Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours) | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period | From start to end of study treatment, up to 48 (±6) hours | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | % of observations | MEAN |
| SECONDARY | Other Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation | From end of study drug treatment to extubation (up to 7 Days after randomization) | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Time to extubation (minutes) | MEDIAN |
| SECONDARY | Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30 | From start of study treatment up to 30 days | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Days | LEAST_SQUARES_MEAN |
| SECONDARY | Other Secondary: To Compare the Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU | From start of study treatment up to 30 days | This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants) | Days | LEAST_SQUARES_MEAN |
| SECONDARY | Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment | From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation) | This Outcome Measure was pre-specified to be assess based on the Safety Population (run-in patients and Randomized participants that received any study drug) | Days | MEAN |
| SECONDARY | Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization | At 30 days after randomization | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients | Isoflurane | 72 | Standard Deviation 26.6 | percentage of time | |
| Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients | Propofol | 73.7 | Standard Deviation 29.15 | percentage of time | |
| Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period | Isoflurane | -0.29 | Standard Deviation 0.91 | µg/kg/hr fentanyl equivalents | |
| Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period | Propofol | 0.03 | Standard Deviation 0.601 | µg/kg/hr fentanyl equivalents | |
| Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment | Isoflurane | 13.0 | Inter-Quartile Range 5.0 to 50.0 | minutes | |
| Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment | Propofol | 17.0 | Inter-Quartile Range 7.0 to 30.0 | minutes | |
| Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | Isoflurane | No Delirium (CAM-ICU7 0-2) | 20 | Participants | |
| Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | Propofol | No Delirium (CAM-ICU7 0-2) | 23 | Participants | |
| Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | Isoflurane | Mild/Moderate Delirium (CAM-ICU7 3-5) | 9 | Participants | |
| Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment | Propofol | Mild/Moderate Delirium (CAM-ICU7 3-5) | 5 | Participants |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Isoflurane (Run-ins) | 47 | |
| Overall Study | STARTED | Isoflurane | 142 | |
| Overall Study | STARTED | Propofol | 93 | |
| Overall Study | COMPLETED | Isoflurane (Run-ins) | 46 | |
| Overall Study | COMPLETED | Isoflurane | 112 | |
| Overall Study | COMPLETED | Propofol | 78 | |
| Overall Study | NOT COMPLETED | Isoflurane (Run-ins) | 1 | |
| Overall Study | NOT COMPLETED | Isoflurane | 30 | |
| Overall Study | NOT COMPLETED | Propofol | 15 |
Source ClinicalTrials.gov
Adverse events148
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Isoflurane (Run-ins and Randomized) | 9 | 173 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Propofol | 5 | 87 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Isoflurane (Run-ins and Randomized) | 9 | 173 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Propofol | 5 | 87 | 5 |
| other | Leukocytosis | Blood and lymphatic system disorders | Isoflurane (Run-ins and Randomized) | 7 | 173 | 7 |
| other | Leukocytosis | Blood and lymphatic system disorders | Propofol | 5 | 87 | 5 |
| other | Liver injury | Hepatobiliary disorders | Isoflurane (Run-ins and Randomized) | 5 | 173 | 5 |
| other | Liver injury | Hepatobiliary disorders | Propofol | 6 | 87 | 6 |
| other | Drug-induced liver injury | Hepatobiliary disorders | Isoflurane (Run-ins and Randomized) | 5 | 173 | 5 |
| other | Drug-induced liver injury | Hepatobiliary disorders | Propofol | 5 | 87 | 5 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Isoflurane (Run-ins and Randomized) | 58 | 173 |
| Total, all-cause mortality | Propofol | 34 | 87 |
| Total, other adverse events | Isoflurane (Run-ins and Randomized) | 92 | 173 |
| Total, other adverse events | Propofol | 52 | 87 |
| Total, serious adverse events | Isoflurane (Run-ins and Randomized) | 33 | 173 |
| Total, serious adverse events | Propofol | 24 | 87 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Isoflurane vs Propofol: Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization | Trial comparisons |
| Isoflurane (Run-ins and Randomized) vs Propofol: Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization | Trial comparisons |
| Isoflurane (Run-ins and Randomized) vs Propofol: Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol | Trial comparisons |
| Isoflurane (Run-ins and Randomized) vs Propofol: deaths from any cause | Trial comparisons |
| Isoflurane vs Propofol: Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization | Trial comparisons |
| Isoflurane (Run-ins and Randomized) vs Propofol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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