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Trial · NCT05327296

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage 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 PatientsFrom 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 timeMEAN
SECONDARYKey Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment PeriodFrom 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 equivalentsMEAN
SECONDARYKey Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug TreatmentUp 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)minutesMEDIAN
SECONDARYKey Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug TreatmentAt 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)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYKey Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment PeriodFrom start to end of study treatment, up to 48 (±6) hoursThis Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)% of observationsMEAN
SECONDARYOther Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for ExtubationFrom 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
SECONDARYOther Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30From start of study treatment up to 30 daysThis Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)DaysLEAST_SQUARES_MEAN
SECONDARYOther Secondary: To Compare the Effect of Isoflurane vs Propofol on Days Alive and Free of the ICUFrom start of study treatment up to 30 daysThis Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)DaysLEAST_SQUARES_MEAN
SECONDARYOther Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study TreatmentFrom 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)DaysMEAN
SECONDARYOther Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After RandomizationAt 30 days after randomizationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYOther Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After RandomizationAt 3 months after randomizationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYOther Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After RandomizationAt 6 months after randomizationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYOther Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving IsofluraneFrom start to end of study treatment (up to 48 (±6) hours)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)Device DeficienciesNUMBER
SECONDARYOther Secondary: The Use of Restraints in Patients Receiving Isoflurane vs PropofolFrom start to end of study treatment (up to 48 (±6) hours)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)ParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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