SedationPhase 3IsoCOMFORTNCT04684238

Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old

A Phase 3 study testing Midazolam and Isoflurane in people with Sedation, run by Sedana Medical at 24 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 3 to 17 years
Conditions the study is for: Sedation
What is being tested?: Midazolam and Isoflurane
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 24 sitesin 5 countries
Study dates: 14 Jan 2021to 19 Jan 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients at least 3 years to 17 (less than 18) years at the time of randomization, admitted to an ICU/with planned ICU admission.
Expected mechanical (invasive) ventilation and sedation for at least 12 hours.
Informed consent obtained from the patient, patient's legal guardian(s)

Who cannot join

Ongoing seizures requiring acute treatment.
Continuous sedation for more than 72 hours at time of randomization.
Less than 24 hours post cardiopulmonary resuscitation.
Uncompensated circulatory shock.
Known or suspected genetic susceptibility to malignant hyperthermia.
Patients with acute asthma or obstructive lung disease symptoms requiring treatment at inclusion.

Show all 13Show fewer

Patient with tidal volume below 30 mL or above 800 mL.
Inability to perform reliable COMFORT-B assessment in the opinion of the Investigator
Patients with intracranial pressure (ICP) monitoring or with suspected increase in ICP
Patients with treatment-induced whole-body hypothermia.
Patients with pheochromocytoma.
Patients with prolonged QT interval or with significant risk for prolonged QT interval.
Patient not expected to survive next 48 hours or not committed to full medical care.

Trial locations and contacts

24 sites in 5 countries.

Country

City, postcode or hospital

24 sites in 5 countries

Spain9 sites

Hospital Materno Infantil Sant Joan de Deu Hospital
Barcelona
Hospital Universitario Reina Sofía
Córdoba
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Infantil Universitario Niño Jesús Pediatric Intensive Care Unit
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Regional Universitario, Carlos Haya
Málaga
Hospital Universitario Virgen del Rocio de Sevilla
Seville
Hospital Universitari i Politecnic La Fe
Valencia

Other trials in Spain

France6 sites

Hôpital Femme-Mère-Enfant Groupe Hospitalier Est
Lyon
CHU de NANTES, Hôpital Mère-Enfant
Nantes
Hôpital Robert-Debré AP-HP
Paris
Hôpitaux Universitaires Paris Sud Site Bicetre
Paris
Centre Hospitalier Universitaire de Reims
Reims
Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre
Strasbourg

Other trials in France

Germany4 sites

Universitätsklinikum Köln
Cologne
Universitätsklinik Freiburg
Freiburg im Breisgau
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg
Universitätsklinikum Jena
Jena

Other trials in Germany

United Kingdom4 sites

Leeds Teaching Hospitals NHS Trust
Leeds
University Hospitals of Leicester NHS Trust
Leicester
Imperial College Healthcare NHS Trust
London
Royal Manchester Children's Hospital
Manchester

Other trials in United Kingdom

Sweden1 site

Karolinska Universitetssjukhus Solna
Solna

Other trials in Sweden

About this study

Official title: A Randomised Active-controlled Study to Compare Efficacy & Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) vs IV Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3-17 Years Old

Read the detailed description

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).

Conditions: Sedation
Being tested: Midazolam, Isoflurane
Keywords: sedation, isoflurane, mechanically ventilation, pediatric, midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MidazolamDrug
Solution for Injection/Infusion
IsofluraneDrug
Inhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device)

Study groups in NCT04684238
Study group	Role	What they receive
Drug: Midazolam	Active comparator	Midazolam for sedation in the ICU Receives: Drug: Midazolam
Drug: Isoflurane	Experimental	Volatile for sedation in the ICU Receives: Drug: Isoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Minimum of 12 hours up to 48 hours (± 6 hours).

Secondary outcomes (12)

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.
Measured: From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From start of study treatment up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 202119 Jan 2023

First posted24 Dec 2020
Study start14 Jan 2021
Primary completion19 Jan 2023
Study completion19 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (16)Papers the sponsor has linked to this study.
Other trials for SedationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04684238
Sponsor's protocol ID: SED002
Acronym: IsoCOMFORT
Status last verified: May 2025
First submitted: 18 Dec 2020
Last updated: 25 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23797368
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.
PubMed 20122588
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.
PubMed 23643411
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.
PubMed 22380747
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.
PubMed 22079951
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.
PubMed 24717461
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.
PubMed 18614330
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.
PubMed 16013698
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.
PubMed 30059477
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.
PubMed 29727363
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.
PubMed 16699772
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.
PubMed 15640636
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.
PubMed 16176317
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.
PubMed 10890677
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.
PubMed 23778830

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety

All Sedation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Active-controlled Study to Compare Efficacy & Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) vs IV Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3-17 Years Old
ClinicalTrials.gov ID: NCT04684238
Acronym / sponsor ID: IsoCOMFORT / SED002
Conditions: Sedation
Keywords: sedation, isoflurane, mechanically ventilation, pediatric, midazolam
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Sedana MedicalIndustry (pharma, biotech, devices)
Study start: 14 Jan 2021 (actual)
Primary completion: 19 Jan 2023 (actual)
Study completion: 19 Jan 2023 (actual)
First posted: 24 Dec 2020 (actual)
Results: Posted 25 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Drug: Midazolam	Active comparator	Drug: MidazolamMidazolam for sedation in the ICU
Drug: Isoflurane	Experimental	Drug: IsofluraneVolatile for sedation in the ICU

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Patients at least 3 years to 17 (less than 18) years at the time of randomization, admitted to an ICU/with planned ICU admission.
Expected mechanical (invasive) ventilation and sedation for at least 12 hours.
Informed consent obtained from the patient, patient's legal guardian(s)

Key exclusion criteria (13 listed)

Ongoing seizures requiring acute treatment.
Continuous sedation for more than 72 hours at time of randomization.
Less than 24 hours post cardiopulmonary resuscitation.
Uncompensated circulatory shock.
Known or suspected genetic susceptibility to malignant hyperthermia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MidazolamSolution for Injection/Infusion	Drug	Drug: Midazolam
IsofluraneInhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device)	Drug	Drug: Isoflurane

Primary outcome

Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours)
Time frame: Minimum of 12 hours 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)

12 secondary outcomes

Compare the Use of Opioids
Time frame: From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period
Compare the Use of Opioids
Time frame: 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 frame: From end of study drug administration to extubation or end of extubation attempt
Compare the Proportion of Time With Spontaneous Breathing
Time frame: 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
Time frame: From start of study treatment to end of study treatment (up to 48h +/- 6h)
Evaluate the Number of Patients With Withdrawal Symptom
Time frame: 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
Time frame: 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
Time frame: During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam
Compare the 30 Days/Hospital Mortality
Time frame: From start of study treatment up to 30 days
Compare Ventilator-free Days
Time frame: From start of study treatment up to 30 days
Compare the Time in ICU/Hospital
Time frame: From start of study treatment up to 30 days
Compare ICU-free Days
Time frame: From start of study treatment up to 30 days

Results and safety

Results posted to the registry on 25 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drug: Midazolam	33	31
Drug: Isoflurane	61	60

Primary outcome: Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours)

Time frame: Minimum of 12 hours up to 48 hours (± 6 hours).. Least squares mean (95% Confidence Interval). Unit: Percentage of time

Measure	Drug: Midazolam n = 33	Drug: Isoflurane n = 59
Value	62.37 (44.70 to 80.04)	68.94 (52.83 to 85.05)

Drug: Midazolam vs Drug: Isoflurane: Least square means: 6.57 (95% CI -8.99 to 22.13), Mixed Models Analysis

Population analysed: 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.

Primary outcome: Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours)

Time frame: Minimum of 12 hours up to 48 hours (± 6 hours).. Least squares mean (95% Confidence Interval). Unit: Percentage of time

Measure	Drug: Midazolam n = 29	Drug: Isoflurane n = 56
Value	65.57 (44.03 to 87.11)	70.91 (50.75 to 91.07)

Drug: Midazolam vs Drug: Isoflurane: Least square means: 5.34 (95% CI -10.48 to 21.17)

Population analysed: 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.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drug: Midazolam	8 of 33 (24.2%)	13 of 33 (39.4%)	2 of 33
Drug: Isoflurane	19 of 61 (31.1%)	32 of 61 (52.5%)	1 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23797368Eifinger 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.
Background: PubMed 20122588Ariyama 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.
Background: PubMed 23643411Grant 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.
Background: PubMed 22380747Hoemberg 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.
Background: PubMed 22079951Kruessell 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.
Background: PubMed 24717461Kudchadkar 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.
Background: PubMed 18614330Nolent 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.
Background: PubMed 16013698Meiser 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.
Background: PubMed 30059477Meyburg 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.
Background: PubMed 29727363Mody 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.
Background: PubMed 16699772Playfor 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.
Background: PubMed 15640636Sackey 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.
Individual participant dataSharing planned: No

Related trials for Sedation

Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Sackey, MD, PhD study director

Sedana Medical

24 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Midazolam and Isoflurane in people with Sedation, run by Sedana Medical at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Spain, France, Germany, United Kingdom, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) (time frame: Minimum of 12 hours up to 48 hours (± 6 hours).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04684238, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.