Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device (ACD)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.
This is a phase III, multi-centre, prospective, randomized, active-controlled, assessor-blind study. Primary endpoint: percentage of time of adequately maintained sedation, in absence of rescue sedation, within the COMFORT-B interval (light, moderate, or deep sedation) prescribed at randomization, monitored every 2 hours for an expected minimum of 12 hours (up to 48 hours).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Midazolam | Active Comparator | Midazolam for sedation in the ICU |
|
| Drug: Isoflurane | Experimental | Volatile for sedation in the ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Solution for Injection/Infusion |
| |
| Isoflurane |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Percentage of time of adequately maintained sedation within the COMFORT-B interval (light, moderate or deep sedation) prescribed at randomisation, monitored every 2 h for a minimum of 12 h (up to 48 h ± 6 h) | Minimum of 12 hours up to 48 hours (± 6 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Use of Opioids | Dose of opioids from first blinded COMFORT-B assessment (at +2 h from start of study drug) to end of study treatment period. This was a key secondary efficacy endpoint. Dose of opioids was expressed as fentanyl IV equivalents. | From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Sackey, MD, PhD | Sedana Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Femme-Mère-Enfant Groupe Hospitalier Est | Lyon | France | ||||
| CHU de NANTES, Hôpital Mère-Enfant |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23797368 | Background | Eifinger F, Hunseler C, Roth B, Vierzig A, Oberthuer A, Mehler K, Kribs A, Menzel C, Trieschmann U. Observations on the effects of inhaled isoflurane in long-term sedation of critically Ill children using a modified AnaConDa(c)-system. Klin Padiatr. 2013 Jul;225(4):206-11. doi: 10.1055/s-0033-1345173. Epub 2013 Jun 24. | |
| 20122588 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
96 patients were randomised in total, 2 patients randomised to isoflurane did not receive treatment and 3 patients receiving treatment did not complete (1 patient receiving isoflurane and 2 patients receiving midazolam)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Drug: Midazolam | Midazolam for sedation in the ICU Midazolam: Solution for Injection/Infusion |
| FG001 | Drug: Isoflurane | Volatile for sedation in the ICU Isoflurane: Inhalation vapour, liquid. Isoflurane delivered by the Anaesthetic Conserving Device (ACD), i.e., Sedaconda ACD-S. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Inhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device) |
|
| Compare the Use of Opioids | Dose of opioids during the last 4 h of study treatment, as compared to the first 4 h of study treatment after first blinded COMFORT-B assessment. This was a key secondary efficacy endpoint. Dose of opioids is expressed as fentanyl IV equivalents. | Last 4 hours of study treatment compared to first 4 hours of study treatment after first blinded COMFORT-B assessment (at +2 h from start of study drug initiation). |
| Compare Time From End of Study Drug Administration to Extubation | Time from end of study drug administration to extubation if study drug was terminated for extubation | From end of study drug administration to extubation or end of extubation attempt |
| Compare the Proportion of Time With Spontaneous Breathing | Proportion of observations with spontaneous breathing efforts during study treatment. This was a key secondary safety endpoint. | From initiation of study drug treatment to End of study treatment (up to 48h +/- 6h) |
| Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent | Need for additional inotropic/vasopressor agent defined by change in Vasoactive-Inotropic Score (VIS) during study treatment period compared to baseline. The VIS quantifies the amount of cardiovascular support required by infants postoperatively according to the below calculation: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (U/kg/min). An increased VIS score correlates to an increase in inotropic/vasopressor agents. | From start of study treatment to end of study treatment (up to 48h +/- 6h) |
| Evaluate the Number of Patients With Withdrawal Symptom | Evaluate the frequency of withdrawal symptoms in isoflurane- vs midazolam-treated patients according to SOS-PD. | From > 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. |
| Evaluate the Frequency of Delirium | Evaluate the frequency of delirium in isoflurane- vs midazolam-treated patients | Patients admitted to the ICU ≥48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. |
| Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction | Evaluate the frequency of neurological symptoms or psychomotor dysfunction during and up to 48 hours after discontinuation of isoflurane and midazolam treatment, and the association with duration of treatment, and total exposure (MAC hours and midazolam doses) over time. | During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam |
| Compare the 30 Days/Hospital Mortality | Compare the 30 days/hospital mortality in isoflurane- vs midazolam-treated patients | From start of study treatment up to 30 days |
| Compare Ventilator-free Days | Ventilator-free days at 30 days from start of study treatment period. | From start of study treatment up to 30 days |
| Compare the Time in ICU/Hospital | Compare the time in ICU at 30 days from start of study treatment period. This was a secondary safety endpoint. Patients that were withdrawn prior to day 30 were excluded from the analysis. Patients who died before day 30 were not considered withdrawals. For these patients, the days in ICU until day of death were considered ICU days. | From start of study treatment up to 30 days |
| Compare ICU-free Days | Compare ICU-free days up to 30 days in isoflurane- vs midazolam-treated patients. | From start of study treatment up to 30 days |
| Nantes |
| France |
| Hôpital Robert-Debré AP-HP | Paris | France |
| Hôpitaux Universitaires Paris Sud Site Bicetre | Paris | France |
| Centre Hospitalier Universitaire de Reims | Reims | France |
| Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre | Strasbourg | France |
| Universitätsklinikum Köln | Cologne | Germany |
| Universitätsklinik Freiburg | Freiburg im Breisgau | Germany |
| Universitätsklinikum Hamburg-Eppendorf (UKE) | Hamburg | Germany |
| Universitätsklinikum Jena | Jena | Germany |
| Hospital Materno Infantil Sant Joan de Deu Hospital | Barcelona | Spain |
| Hospital Universitario Reina Sofía | Córdoba | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Infantil Universitario Niño Jesús Pediatric Intensive Care Unit | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Regional Universitario, Carlos Haya | Málaga | Spain |
| Hospital Universitario Virgen del Rocio de Sevilla | Seville | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | Spain |
| Karolinska Universitetssjukhus Solna | Solna | Sweden |
| Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
| Imperial College Healthcare NHS Trust | London | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | United Kingdom |
| Ariyama J, Hayashida M, Shibata K, Sugimoto Y, Imanishi H, O-oi Y, Kitamura A. Risk factors for the development of reversible psychomotor dysfunction following prolonged isoflurane inhalation in the general intensive care unit. J Clin Anesth. 2009 Dec;21(8):567-73. doi: 10.1016/j.jclinane.2009.01.011. |
| 23643411 | Background | Grant MJ, Balas MC, Curley MA; RESTORE Investigative Team. Defining sedation-related adverse events in the pediatric intensive care unit. Heart Lung. 2013 May-Jun;42(3):171-6. doi: 10.1016/j.hrtlng.2013.02.004. |
| 22380747 | Background | Hoemberg M, Vierzig A, Roth B, Eifinger F. Plasma fluoride concentrations during prolonged administration of isoflurane to a pediatric patient requiring renal replacement therapy. Paediatr Anaesth. 2012 Apr;22(4):412-3. doi: 10.1111/j.1460-9592.2012.03814.x. No abstract available. |
| 22079951 | Background | Kruessell MA, Udink ten Cate FE, Kraus AJ, Roth B, Trieschmann U. Use of propofol in pediatric intensive care units: a national survey in Germany. Pediatr Crit Care Med. 2012 May;13(3):e150-4. doi: 10.1097/PCC.0b013e3182388a95. |
| 24717461 | Background | Kudchadkar SR, Yaster M, Punjabi NM. Sedation, sleep promotion, and delirium screening practices in the care of mechanically ventilated children: a wake-up call for the pediatric critical care community*. Crit Care Med. 2014 Jul;42(7):1592-600. doi: 10.1097/CCM.0000000000000326. |
| 18614330 | Background | Nolent P, Laudenbach V. [Sedation and analgesia in the paediatric intensive care unit]. Ann Fr Anesth Reanim. 2008 Jul-Aug;27(7-8):623-32. doi: 10.1016/j.annfar.2008.04.014. Epub 2008 Jul 9. French. |
| 16013698 | Background | Meiser A, Laubenthal H. Inhalational anaesthetics in the ICU: theory and practice of inhalational sedation in the ICU, economics, risk-benefit. Best Pract Res Clin Anaesthesiol. 2005 Sep;19(3):523-38. doi: 10.1016/j.bpa.2005.02.006. |
| 30059477 | Background | Meyburg J, Dill ML, von Haken R, Picardi S, Westhoff JH, Silver G, Traube C. Risk Factors for the Development of Postoperative Delirium in Pediatric Intensive Care Patients. Pediatr Crit Care Med. 2018 Oct;19(10):e514-e521. doi: 10.1097/PCC.0000000000001681. |
| 29727363 | Background | Mody K, Kaur S, Mauer EA, Gerber LM, Greenwald BM, Silver G, Traube C. Benzodiazepines and Development of Delirium in Critically Ill Children: Estimating the Causal Effect. Crit Care Med. 2018 Sep;46(9):1486-1491. doi: 10.1097/CCM.0000000000003194. |
| 16699772 | Background | Playfor S, Jenkins I, Boyles C, Choonara I, Davies G, Haywood T, Hinson G, Mayer A, Morton N, Ralph T, Wolf A; United Kingdom Paediatric Intensive Care Society Sedation; Analgesia and Neuromuscular Blockade Working Group. Consensus guidelines on sedation and analgesia in critically ill children. Intensive Care Med. 2006 Aug;32(8):1125-36. doi: 10.1007/s00134-006-0190-x. Epub 2006 May 13. |
| 15640636 | Background | Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6. doi: 10.1097/01.ccm.0000145951.76082.77. |
| 16176317 | Background | Sackey PV, Martling CR, Radell PJ. Three cases of PICU sedation with isoflurane delivered by the 'AnaConDa'. Paediatr Anaesth. 2005 Oct;15(10):879-85. doi: 10.1111/j.1460-9592.2005.01704.x. |
| 10890677 | Background | Tobias JD. Tolerance, withdrawal, and physical dependency after long-term sedation and analgesia of children in the pediatric intensive care unit. Crit Care Med. 2000 Jun;28(6):2122-32. doi: 10.1097/00003246-200006000-00079. |
| 23778830 | Background | Vet NJ, Ista E, de Wildt SN, van Dijk M, Tibboel D, de Hoog M. Optimal sedation in pediatric intensive care patients: a systematic review. Intensive Care Med. 2013 Sep;39(9):1524-34. doi: 10.1007/s00134-013-2971-3. Epub 2013 Jun 19. |
| 40680761 | Derived | Miatello J, Palacios-Cuesta A, Radell P, Oberthuer A, Playfor S, Amores-Hernandez I, Barreault S, Biedermann R, Charlo Molina MT, Encarnacion Martinez J, Kuehne B, Mencia S, Mendez MD, Menzel C, Morin L, Oviedo L, Piloquet JE, Falkenhav M, Sackey P, Trieschmann U, Tissieres P; IsoCOMFORT Study Group. Inhaled isoflurane for sedation of mechanically ventilated children in intensive care (IsoCOMFORT): a multicentre, randomised, active-control, assessor-masked, non-inferiority phase 3 trial. Lancet Respir Med. 2025 Oct;13(10):897-910. doi: 10.1016/S2213-2600(25)00203-6. Epub 2025 Jul 15. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Drug: Midazolam | Midazolam for sedation in the ICU Midazolam: Solution for Injection/Infusion |
| BG001 | Drug: Isoflurane | Volatile for sedation in the ICU Isoflurane: Inhalation vapour, liquid. Isoflurane delivered by the Sedaconda ACD-S device |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Data missing for 1 patient in the Isoflurane group. Safety set | Mean | Standard Deviation | kg |
| ||||||||||||||
| Height | Data missing from 3 patients in the Isoflurane group and from 1 patient in the Midazolam group. Safety set | Mean | Standard Deviation | cm |
| ||||||||||||||
| Height | Missing data for 3 patients in Isoflurane group and from 1 patient in Midazolam group. Safety set. | Median | Full Range | cm |
| ||||||||||||||
| Weight | Data missing for 1 patient in the Isoflurane group. Safety set | Median | Full Range | kg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Percentage of time of adequately maintained sedation within the COMFORT-B interval (light, moderate or deep sedation) prescribed at randomisation, monitored every 2 h for a minimum of 12 h (up to 48 h ± 6 h) | Full Analysis set (FAS): The FAS included all randomised patients who received IMP and had at least a 6-hour sedation period and at least 3 blinded COMFORT-B-assessments. The FAS followed the intention-to-treat principle, i.e., patients were analysed according to the treatment group they were assigned to at randomisation. The main statistical analysis was performed on this population. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of time | Minimum of 12 hours up to 48 hours (± 6 hours). |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Percentage of time of adequately maintained sedation within the COMFORT-B interval (light, moderate or deep sedation) prescribed at randomisation, monitored every 2 h for a minimum of 12 h (up to 48 h ± 6 h) | The PP analysis set included all patients in the FAS without any major protocol deviation affecting the primary analysis. To be included in the PP analysis patients had to have been sedated for at least 12h (which was interpreted as 12 h of study sedative treatment from start of IMP), with at least 50% of the planned COMFORT-B assessments performed. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of time | Minimum of 12 hours up to 48 hours (± 6 hours). |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Use of Opioids | Dose of opioids from first blinded COMFORT-B assessment (at +2 h from start of study drug) to end of study treatment period. This was a key secondary efficacy endpoint. Dose of opioids was expressed as fentanyl IV equivalents. | The FAS included all randomised patients who received IMP and had at least a 6-hour sedation period and at least 3 blinded COMFORT-B-assessments. The FAS followed the intention-to-treat (ITT) principle, i.e., patients were analysed according to the treatment group they were assigned to at randomisation. | Posted | Least Squares Mean | 95% Confidence Interval | μg/kg/h | From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Use of Opioids | Dose of opioids during the last 4 h of study treatment, as compared to the first 4 h of study treatment after first blinded COMFORT-B assessment. This was a key secondary efficacy endpoint. Dose of opioids is expressed as fentanyl IV equivalents. | FAS: Patients with 8 hours or more of study treatment from first blinded COMFORT-B assessment. | Posted | Least Squares Mean | 95% Confidence Interval | μg/kg/h | Last 4 hours of study treatment compared to first 4 hours of study treatment after first blinded COMFORT-B assessment (at +2 h from start of study drug initiation). |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare Time From End of Study Drug Administration to Extubation | Time from end of study drug administration to extubation if study drug was terminated for extubation | Subgroup of patients with endotracheal tube where wake-up was initiated at end of study treatment | Posted | Mean | Inter-Quartile Range | hour | From end of study drug administration to extubation or end of extubation attempt |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Proportion of Time With Spontaneous Breathing | Proportion of observations with spontaneous breathing efforts during study treatment. This was a key secondary safety endpoint. | Full Analysis Set | Posted | Least Squares Mean | 95% Confidence Interval | proportion of time | From initiation of study drug treatment to End of study treatment (up to 48h +/- 6h) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent | Need for additional inotropic/vasopressor agent defined by change in Vasoactive-Inotropic Score (VIS) during study treatment period compared to baseline. The VIS quantifies the amount of cardiovascular support required by infants postoperatively according to the below calculation: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (U/kg/min). An increased VIS score correlates to an increase in inotropic/vasopressor agents. | Safety analysis set | Posted | Mean | Standard Deviation | Change from baseline in VIS | From start of study treatment to end of study treatment (up to 48h +/- 6h) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate the Number of Patients With Withdrawal Symptom | Evaluate the frequency of withdrawal symptoms in isoflurane- vs midazolam-treated patients according to SOS-PD. | Posted | Count of Participants | Participants | From > 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate the Frequency of Delirium | Evaluate the frequency of delirium in isoflurane- vs midazolam-treated patients | Posted | Count of Participants | Participants | Patients admitted to the ICU ≥48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction | Evaluate the frequency of neurological symptoms or psychomotor dysfunction during and up to 48 hours after discontinuation of isoflurane and midazolam treatment, and the association with duration of treatment, and total exposure (MAC hours and midazolam doses) over time. | Posted | Count of Participants | Participants | During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare the 30 Days/Hospital Mortality | Compare the 30 days/hospital mortality in isoflurane- vs midazolam-treated patients | Posted | Count of Participants | Participants | From start of study treatment up to 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare Ventilator-free Days | Ventilator-free days at 30 days from start of study treatment period. | Safety analysis set (only patients not withdrawn prior to day 30) | Posted | Mean | Standard Deviation | Number of ventilator-free days | From start of study treatment up to 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare the Time in ICU/Hospital | Compare the time in ICU at 30 days from start of study treatment period. This was a secondary safety endpoint. Patients that were withdrawn prior to day 30 were excluded from the analysis. Patients who died before day 30 were not considered withdrawals. For these patients, the days in ICU until day of death were considered ICU days. | Safety analysis set (only patients not withdrawn prior to day 30) | Posted | Mean | Standard Deviation | Number of ICU days | From start of study treatment up to 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Compare ICU-free Days | Compare ICU-free days up to 30 days in isoflurane- vs midazolam-treated patients. | Safety analysis set (only patients not withdrawn prior to day 30). This was a secondary safety endpoint. Patients who died before day 30 were not considered withdrawals. For these patients, the days in ICU until day of death were considered ICU days. | Posted | Mean | Standard Deviation | Number of days alive and not in the ICU | From start of study treatment up to 30 days |
|
|
Adverse events (AEs) were recorded during the study drug treatment period (up to 48h +/- 6h from start of IMP) and for 48 hours after end of study drug treatment. Mortality was monitored for up to 30 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Drug: Midazolam | Midazolam for sedation in the ICU Midazolam: Solution for Injection/Infusion | 2 | 33 | 8 | 33 | 13 | 33 |
| EG001 | Drug: Isoflurane | Volatile for sedation in the ICU Isoflurane: Inhalation vapour, liquid. Isoflurane delivered by the Sedaconda ACD-S. | 1 | 61 | 19 | 61 | 32 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Magnetic resonance imaging head abnormal | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Anaesthetic complication neurological | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Complications of transplanted liver subjects affected / exposed | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Postoperative wound infection | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyelonephritis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperthermia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ida Sverud | Sedana Medical AB | +46 8 124 052 00 | medinfo@sedanamedical.com |
| Feb 20, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D007530 | Isoflurane |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Adolescents (12-17 years) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|