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CompletedNCT05312385INSPiRE-ICU1Updated Mar 24, 2026Results posted

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-ICU1)

A Phase 3 interventional study of Isoflurane and Propofol in Sedation, sponsored by Sedana Medical. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Sedana Medical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
277
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.

Read the detailed description

This is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared to intravenous propofol for sedation of mechanically ventilated Intensive Care Unit (ICU) adult patients.

02

Conditions studied

  • Sedation

Keywords

  • sedation
  • mechanical ventilation
  • isoflurane
  • propofol
  • ICU
03

In context

Lead sponsor

Sedana Medical is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults ≥18 years of age;
  • Patients who are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU; and
  • Receipt of continuous sedation due to clinical need for sedation to RASS \<0.

Exclusion criteria

Exclusion Criteria:

  • Need for RASS -5;
  • Sedation for invasive mechanical ventilation immediately prior to Baseline for >72 hours;
  • Severe neurological condition before ICU admission that causes the patient to lack ability to participate in the study (ie, unable to be assessed for RASS and CPOT);
  • Ventilator tidal volume \<200 or >1000 mL at Baseline;
  • Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive ventilation (HFPV) at Screening;
  • Comfort care only (end of life care);
  • Contraindication to propofol or isoflurane;
  • Known or family history of MH;
  • Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min (or equivalent vasopressor dose) to maintain blood pressure within acceptable range, assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;
  • Allergy to isoflurane or propofol, or have propofol infusion syndrome.
  • History of ventricular tachycardia/Long QT Syndrome;
  • Requirement of IV benzodiazepine or barbiturate administration for seizures or dependencies, including alcohol withdrawal
  • Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, etc);
  • Concurrent enrollment in another study that, in the Investigator's opinion, would impact the patient's safety or assessments of this study;
  • Participation in other study involving investigational drug(s) or devices(s) within 30 days prior to Randomization;
  • Anticipated requirement of treatment with continuous infusion of a neuromuscular blocking agent for >4 hours;
  • Female patients who are pregnant or breast-feeding;
  • Imperative need for continuous active humidification through mechanical ventilation circuit;
  • Attending physician's refusal to include the patient; or
  • Inability to obtain informed consent.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
277 participants (actual)

Study arms

  • Experimental
    Isoflurane

    Inhaled isoflurane administered via Sedaconda ACD-S

    Drug: Isoflurane · Drug: Isoflurane (run-ins)

  • Active comparator
    Propofol

    Propofol administered as intravenous infusion

    Drug: Propofol

Interventions

  • DrugIsoflurane

    Inhaled isoflurane administered by Sedaconda ACD-S

  • DrugPropofol

    Intravenous infusion of propofol

  • DrugIsoflurane (run-ins)

    Inhaled isoflurane administered by Sedaconda ACD-S 3-5 run-in patients were enrolled at each site prior to randomization

06

What researchers measure

Primary outcomes

  1. The 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

    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.

    Time frame: From start to end of study treatment (up to 48 (±6) hours)

Secondary outcomes

  1. Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period

    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

    Time frame: From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours)

  2. Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment

    Time frame: Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours)

  3. Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment

    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.

    Time frame: At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours)

  4. Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period

    Proportion of ventilator parameter observations with spontaneous breathing efforts during the study drug treatment period

    Time frame: From start to end of study treatment, up to 48 (±6) hours

  5. 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

    To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation

    Time frame: From end of study treatment sedation to extubation (up to 7 Days after randomization)

  6. Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30

    Time frame: From start of study treatment up to 30 days

  7. Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU

    Time frame: From start of study treatment up to 30 days

  8. Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment

    Time frame: From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation)

  9. Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization

    Participants reported represent participants that died between randomization and 30 days in the Safety population

    Time frame: At 30 days after randomization

  10. Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization

    Participants reported represent participants that died between randomization and 3 months in the Safety population

    Time frame: At 3 months after randomization

  11. Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization

    Participants reported represent participants that died between randomization and 6 months in the Safety population

    Time frame: At 6 months after randomization

  12. Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane

    Time frame: From start to end of study treatment (up to 48 (±6) hours)

  13. Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol

    Incidence of restraints measured twice daily

    Time frame: From start to end of study treatment (up to 48 (±6) hours)

07

Results

Posted Mar 24, 2026

Participant flow

Participant flow — Overall Study
MilestoneIsoflurane (Run-ins)IsofluranePropofol
Started4214293
Completed3712784
Not completed5159

Outcome measures

PrimaryThe 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

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.

Time frame:
From start to end of study treatment (up to 48 (±6) hours)
Reported as:
Mean · % of time of adequate sedation depth
The 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
% of time of adequate sedation depthIsofluranePropofol
The 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 Patients70 ± 26.2677.7 ± 28.89
Statistical analysis
  • Isoflurane vs Propofol · ANOVA · p = <0.01 · Ls mean difference: -1.5
SecondaryKey Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period

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

Time frame:
From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours)
Reported as:
Mean · µg/kg/hr fentanyl equivalents
Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period
µg/kg/hr fentanyl equivalentsIsofluranePropofol
Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period-0.26 ± 0.664-0.05 ± 0.519
Statistical analysis
  • Isoflurane vs Propofol · ANOVA · p = 0.0470 · Ls mean difference: -0.135 · 95% CI -0.269 to -0.002
SecondaryKey Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment
Time frame:
Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours)
Reported as:
Median · minutes
Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment
minutesIsofluranePropofol
Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment17 (6.0 to 45.0)27 (10.0 to 95.0)
Statistical analysis
  • Isoflurane vs Propofol · Regression, Cox · p = 0.229 · Hazard ratio (hr): 1.33 · 95% CI 0.84 to 2.10
SecondaryKey Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment

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.

Time frame:
At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours)
Reported as:
Count of participants · Participants
Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment
ParticipantsIsofluranePropofol
No Delirium (CAM-ICU7 0-2)1910
Mild/Moderate Delirium (CAM-ICU7 3-5)99
Severe Delirium (CAM-ICU7 6-7)712
Statistical analysis
  • Isoflurane vs Propofol · Wilcoxon (Mann-Whitney) · p = 0.218 · Location shift: -1 · 95% CI -3.00 to 0.00
SecondaryKey Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period

Proportion of ventilator parameter observations with spontaneous breathing efforts during the study drug treatment period

Time frame:
From start to end of study treatment, up to 48 (±6) hours
Reported as:
Mean · % of spontaneous breathing efforts
Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period
% of spontaneous breathing effortsIsoflurane (Randomized)Propofol (Randomized)
Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period58.9 ± 38.258 ± 35.86
Statistical analysis
  • Isoflurane (Randomized) vs Propofol (Randomized) · ANOVA · p = 0.724 · Ls mean difference: 1.8 · 95% CI -8.1 to 11.7
SecondaryOther Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation

To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation

Time frame:
From end of study treatment sedation to extubation (up to 7 Days after randomization)
Reported as:
Median · minutes
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
minutesIsoflurane (Randomized)Propofol (Randomized)
Other Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation109.5 (34 to 1133)160 (33 to 1480)
Statistical analysis
  • Isoflurane (Randomized) vs Propofol (Randomized) · Regression, Cox · p = 0.066 · Hazard ratio (hr): 1.55 · 95% CI 0.97 to 2.48
SecondaryOther Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30
Time frame:
From start of study treatment up to 30 days
Reported as:
Least squares mean · Days
Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30
DaysIsofluranePropofol
Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 3021.6 (19.17 to 24.02)19.7 (16.96 to 22.48)
Statistical analysis
  • Isoflurane vs Propofol · ANOVA · p = 0.174 · Ls mean difference: 1.9 · 95% CI -0.83 to 4.59
SecondaryOther Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU
Time frame:
From start of study treatment up to 30 days
Reported as:
Least squares mean · Days
Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU
DaysIsoflurane (Randomized)Propofol
Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU15.4 (12.92 to 17.94)13.7 (10.81 to 16.51)
Statistical analysis
  • Isoflurane (Randomized) vs Propofol · ANOVA · p = 0.215 · Ls mean difference: 1.8 · 95% CI -1.02 to 4.59
SecondaryOther Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment
Time frame:
From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation)
Reported as:
Mean · Days
Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment
DaysIsoflurane (Run-ins and Randomized)Propofol (Randomized)
Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment2.5 ± 2.162.4 ± 2.08
Statistical analysis
  • Isoflurane (Run-ins and Randomized) vs Propofol (Randomized) · ANOVA · p = 0.785 · Ls mean difference: 0.1 · 95% CI -0.46 to 0.61
SecondaryOther Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization

Participants reported represent participants that died between randomization and 30 days in the Safety population

Time frame:
At 30 days after randomization
Reported as:
Count of participants · Participants
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization
ParticipantsIsoflurane (Run-ins and Randomized)Propofol
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization3822
Statistical analysis
  • Isoflurane (Run-ins and Randomized) vs Propofol · Cochran-Mantel-Haenszel · p = 0.219 · Difference in percentage: -6.8 · 95% CI -17.6 to 4.0Difference in percentage between Isoflurane vs Propofol with respect to all-cause mortality (negative differences are in favor of Isoflurane). The difference is estimated using CMH using the Miettinen and Nurminen method.
SecondaryOther Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization

Participants reported represent participants that died between randomization and 3 months in the Safety population

Time frame:
At 3 months after randomization
Reported as:
Count of participants · Participants
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization
ParticipantsIsoflurane (Run-ins and Randomized)Propofol
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization5328
Statistical analysis
  • Isoflurane (Run-ins and Randomized) vs Propofol · Cochran-Mantel-Haenszel · p = 0.501 · Difference in percentage: -3.9 · 95% CI -15.1 to 7.4
SecondaryOther Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization

Participants reported represent participants that died between randomization and 6 months in the Safety population

Time frame:
At 6 months after randomization
Reported as:
Count of participants · Participants
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization
ParticipantsIsoflurane (Run-ins and Randomized)Propofol
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization5831
Statistical analysis
  • Isoflurane (Run-ins and Randomized) vs Propofol · Cochran-Mantel-Haenszel · p = 0.415 · Difference in percentage: -4.8 · 95% CI -16.4 to 6.7
SecondaryOther Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane
Time frame:
From start to end of study treatment (up to 48 (±6) hours)
Reported as:
Number · Device Deficiencies
Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane
Device DeficienciesIsoflurane (Run-ins and Randomized)
Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane1
SecondaryOther Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol

Incidence of restraints measured twice daily

Time frame:
From start to end of study treatment (up to 48 (±6) hours)
Reported as:
Count of participants · Participants
Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol
ParticipantsIsoflurane (Run-ins and Randomized)Propofol (Randomized)
Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol14674

Adverse events

Collected over Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Isoflurane (Run-ins and Randomized)58/177 (32.8%)31/177 (17.5%)55/177 (31.1%)
Propofol (Randomized)31/89 (34.8%)14/89 (15.7%)22/89 (24.7%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventIsoflurane (Run-ins and Randomized)Propofol (Randomized)
Septic shockInfections and infestations6/1770/89
HypoxiaRespiratory, thoracic and mediastinal disorders1/1773/89
HypotensionVascular disorders4/1772/89
Multiple organ dysfunction syndromeGeneral disorders0/1772/89
Respiratory failureRespiratory, thoracic and mediastinal disorders1/1772/89
Pneumonia staphylococcalInfections and infestations2/1770/89
Hepatic encephalopathyNervous system disorders2/1770/89
Acute respiratory failureRespiratory, thoracic and mediastinal disorders2/1770/89
Therapy cessationSurgical and medical procedures2/1770/89
ShockVascular disorders2/1771/89
Most frequent other events
Most frequent other events
EventIsoflurane (Run-ins and Randomized)Propofol (Randomized)
HypotensionVascular disorders26/1778/89
HypoxiaRespiratory, thoracic and mediastinal disorders10/1778/89
Liver injuryHepatobiliary disorders10/1775/89
AnaemiaBlood and lymphatic system disorders9/1771/89

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Isoflurane (Run-ins)Isoflurane (Randomized)Propofol (Randomized)Total
<=18 years0000
Between 18 and 65 years228150153
>=65 years206143124
Age, Continuous
Age, Continuous(years)Isoflurane (Run-ins)Isoflurane (Randomized)Propofol (Randomized)Total
Median63.5 (56 to 71)62.5 (50 to 71)64 (52 to 72)63 (50 to 72)
Sex: Female, Male
Sex: Female, Male(Participants)Isoflurane (Run-ins)Isoflurane (Randomized)Propofol (Randomized)Total
Female196339121
Male237954156
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Isoflurane (Run-ins)Isoflurane (Randomized)Propofol (Randomized)Total
Hispanic or Latino1121023
Not Hispanic or Latino3912882249
Unknown or Not Reported2215
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Isoflurane (Run-ins)Isoflurane (Randomized)Propofol (Randomized)Total
American Indian or Alaska Native0101
Asian0415
Native Hawaiian or Other Pacific Islander0101
Black or African American516728
White3511680231
More than one race0224
Unknown or Not Reported2237
Region of Enrollment
Region of Enrollment(participants)Isoflurane (Run-ins)Isoflurane (Randomized)Propofol (Randomized)Total
United States4214293277
08

Study locations

14 sites
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado 80045, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • The Brigham and Women´s Hospital
    Boston, Massachusetts 02115, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Houston Methodist Hospital
    Houston, Texas 77030, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Intermountain Health Care Health Services
    Salt Lake City, Utah 84111, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
09

References and documents

Publications

  • Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299. PubMed 30113379 ↗
  • Shehabi Y, Howe BD, Bellomo R, Arabi YM, Bailey M, Bass FE, Bin Kadiman S, McArthur CJ, Murray L, Reade MC, Seppelt IM, Takala J, Wise MP, Webb SA; ANZICS Clinical Trials Group and the SPICE III Investigators. Early Sedation with Dexmedetomidine in Critically Ill Patients. N Engl J Med. 2019 Jun 27;380(26):2506-2517. doi: 10.1056/NEJMoa1904710. Epub 2019 May 19. PubMed 31112380 ↗
  • Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002. PubMed 10816184 ↗
  • Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872. PubMed 23180503 ↗
  • Sackey PV, Martling CR, Carlsward C, Sundin O, Radell PJ. Short- and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam--a pilot study. Crit Care Med. 2008 Mar;36(3):801-6. doi: 10.1097/CCM.0B013E3181652FEE. PubMed 18431266 ↗
  • Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29. PubMed 21445642 ↗
  • Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26. PubMed 34454654 ↗
  • Kong KL, Willatts SM, Prys-Roberts C. Isoflurane compared with midazolam for sedation in the intensive care unit. BMJ. 1989 May 13;298(6683):1277-80. doi: 10.1136/bmj.298.6683.1277. PubMed 2500195 ↗
  • Chanques G, Constantin JM, Devlin JW, Ely EW, Fraser GL, Gelinas C, Girard TD, Guerin C, Jabaudon M, Jaber S, Mehta S, Langer T, Murray MJ, Pandharipande P, Patel B, Payen JF, Puntillo K, Rochwerg B, Shehabi Y, Strom T, Olsen HT, Kress JP. Analgesia and sedation in patients with ARDS. Intensive Care Med. 2020 Dec;46(12):2342-2356. doi: 10.1007/s00134-020-06307-9. Epub 2020 Nov 10. PubMed 33170331 ↗
  • Jerath A, Ferguson ND, Cuthbertson B. Inhalational volatile-based sedation for COVID-19 pneumonia and ARDS. Intensive Care Med. 2020 Aug;46(8):1563-1566. doi: 10.1007/s00134-020-06154-8. Epub 2020 Jun 25. PubMed 32588067 ↗
  • Bellgardt M, Bomberg H, Herzog-Niescery J, Dasch B, Vogelsang H, Weber TP, Steinfort C, Uhl W, Wagenpfeil S, Volk T, Meiser A. Survival after long-term isoflurane sedation as opposed to intravenous sedation in critically ill surgical patients: Retrospective analysis. Eur J Anaesthesiol. 2016 Jan;33(1):6-13. doi: 10.1097/EJA.0000000000000252. PubMed 25793760 ↗
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  • Krannich A, Leithner C, Engels M, Nee J, Petzinka V, Schroder T, Jorres A, Kruse J, Storm C. Isoflurane Sedation on the ICU in Cardiac Arrest Patients Treated With Targeted Temperature Management: An Observational Propensity-Matched Study. Crit Care Med. 2017 Apr;45(4):e384-e390. doi: 10.1097/CCM.0000000000002185. PubMed 27941501 ↗
  • Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1. PubMed 18191684 ↗
  • Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372. PubMed 24088092 ↗
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Study documents

  • Protocol and statistical analysis plan · Oct 6, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05312385
Lead sponsor
Sedana Medical
Responsible party
Sponsor
First posted
Apr 5, 2022
Start date
Apr 28, 2022
Primary completion
Apr 26, 2024
Completion
Oct 24, 2024
Results posted
Mar 24, 2026
Last update
Mar 24, 2026

Study contacts

Kimberly Rengel, M.D.
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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