Trial · NCT05327296
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization | At 3 months after randomization | Participants reported represent participants that died between randomization and 3 months in the Safety population |
| Secondary | Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization | At 6 months after randomization | Participants reported represent participants that died between randomization and 6 months in the Safety population |
| Secondary | Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane | From start to end of study treatment (up to 48 (±6) hours) | |
| Secondary | Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol | From start to end of study treatment (up to 48 (±6) hours) | Incidence of restraints measured twice daily |
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.
For software
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