Clinical trials: Sedation in Intensive Care
Delirium in the Intensive Care Unit
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours.
- Trial name
- PEDIADEX (NCT07542990)
- Testing
- Dexmedetomidine, Midazolam
- Where
- 7 sites in France
- Volunteers
- 266 people
- Sponsor
- University Hospital, Tours
Conscious Sedation
Efficiency of Ventilation During Conscious Sedation in the Pediatric Intensive Care Unit
Pediatric patients admitted to the intensive care unit and requiring conscious sedation for minor surgical procedures are at risk to hypoventilate and retain CO2. The rise in CO2 levels is not well described and unpredicted.
- Trial name
- NCT01287572
- Where
- Israel
- Volunteers
- 80 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Traumatic Brain Injury, Subarachnoid Hemorrhage
Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation
A study in the use of the Narcotrend depth of anaesthesia monitor to record a) seizures, and b) monitor a level of sedation referred to as 'burst suppression', in sedated patients in the adult and paediatric intensive care.
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracerebral Haemorrhage, Encephalitis
- Trial name
- NCT06067750
- Testing
- Narcotrend compared to Cerebral Function Analysing Monitor (CFAM)
- Where
- United Kingdom
- Volunteers
- 44 people
- Sponsor
- Nottingham University Hospitals NHS Trust
Prolonged Sedation
Dexmedetomidine for Prolonged Sedation in PICUs
Sedation management of the critically ill patients is still a challenge for the pediatric intensivists. Worldwide the most common sedation approach includes the concomitant use of opioids and benzodiazepines.
- Trial name
- PROSDEX (NCT03760978)
- Testing
- Dexmedetomidine
- Where
- 9 sites in Italy
- Volunteers
- 163 people
- Sponsor
- Azienda Ospedaliera di Padova
Sedation Complication, Mechanical Ventilation in Neonates
Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care
This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and undergoing mechanical…
- Trial name
- NCT05371886
- Testing
- Dose-effect relationship of morphine +/- midazolam administration
- Where
- 5 sites in France
- Volunteers
- 180 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Sedation in Intensive Care
Efficacy, Safety and Pharmacokinetic Study of Intravenous Clonidine Versus Midazolam for Sedation in Paediatric Patients
Closed1 aims to compare the efficacy, safety and pharmacokinetics of clonidine (hydrochloride) to midazolam in the sedation of ventilated children and adolescents (0-18 years) admitted to a paediatric intensive care unit (PICU)…
- Trial name
- CloSed1 (NCT02509273)
- Testing
- Clonidine, Midazolam
- Where
- 10 sites in Czechia, Estonia and 5 more
- Volunteers
- 28 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
ICU Sedation
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
- Trial name
- Pedrux (NCT03813277)
- Testing
- Dexmedetomidine
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Orion Corporation, Orion Pharma
Intellectual Disability, Perceptual Disorders
Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood
The purpose of this study is to determine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes.
- Conditions
- Intellectual Disability, Perceptual Disorders, Memory Disorders
- Trial name
- RESTORE-cog (NCT02225041)
- Where
- 31 sites in United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Critical Illness
Development and Evaluation of Strategies to Improve Sedation Quality in InTensive Care
Intensive Care Units (ICUs) across Scotland are working with the Scottish Patient Safety Programme (SPSP) to reduce healthcare associated infections (HAls). This is being done through implementation of "care bundles".
- Trial name
- DESIST (NCT01634451)
- Testing
- Bespoke on-line sedation education package, Sedation specific outcome process feedback, Responsiveness monitoring; novel sedation monitor
- Where
- United Kingdom
- Volunteers
- 1,637 people
- Sponsor
- University of Edinburgh
Analgesia, Deep Sedation
Implementation and Evaluation of a Pediatric Nurse-driven Sedation Protocol in a PICU
Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be…
- Trial name
- SEDATIDE (NCT02829710)
- Testing
- Nurse-driven sedation protocol
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Hospices Civils de Lyon
Sedation
Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children
Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years.
- Trial name
- NCT01091818
- Testing
- dexmedetomidine, Midazolam
- Where
- Norway
- Volunteers
- 40 people
- Sponsor
- Ullevaal University Hospital
Pain, Sedation
Effect of Maternal Voice on Pain, Sedation, and Physiological Parameters in Mechanically Ventilated Children
Children in the pediatric intensive care unit often experience pain and stress from medical procedures, even while sedated. This study will test whether playing a recording of the child's mother's voice helps reduce pain and the…
- Conditions
- Pain, Sedation, Mechanical Ventilation
- Trial name
- NCT07753486
- Testing
- Recorded Maternal Voice
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people
- Sponsor
- TC Erciyes University
Mechanical Ventilation, Sedation
Implementation of an Analgesia-sedation Algorithm in the Pediatric ICU to Reduce Benzodiazepine Use
The purpose of the study is to develop and implement an evidence-based analgesia-sedation algorithm in the pediatric intensive care unit (PICU) using quality improvement and implementation science methodology.
- Trial name
- NCT04263662
- Testing
- Analgesia-Sedation algorithm
- Where
- United States
- Volunteers
- 680 people
- Sponsor
- Boston Children's Hospital
Critical Illness, Respiratory Failure
Sedation in the Intensive Care Unit
High-risk critically ill patients often require mechanical ventilation either to primarily support the respiratory function or when the ventilation is insufficient to maintain adequate gas exchanges as a result of other organ…
- Trial name
- NCT00221520
- Testing
- midazolam with 2 different levels of sedation scores
- Where
- Switzerland
- Volunteers
- 126 people
- Sponsor
- University Hospital, Geneva
Mechanical Ventilation Complication
Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU
Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU). Its use requires almost always the establishment of a sedation.
- Trial name
- PEDIASED (NCT02040168)
- Where
- France
- Volunteers
- 106 people
- Sponsor
- Nantes University Hospital
Bronchiolitis Acute, Pneumonia
Feasibility Study for Neurodevelopment Follow-up Study in PICU
There is a large and growing body of animal evidence demonstrating neuroapoptosis and neurodevelopmental abnormalities after exposure to anesthetic agents.
- Trial name
- PICUFUN (NCT03345628)
- Testing
- Sedatives
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Sedation Complication
Validation of a Processed EEG Device for Monitoring Sedation in PICU
The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs.
- Trial name
- NCT05969483
- Testing
- pEEG monitoring
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Azienda Ospedaliera di Padova
Agitation
Acupuncture to Improve Comfort of Children on a Ventilator in the Intensive Care Unit
The purpose of this study is to determine whether acupuncture is effective at improving comfort in children on a ventilator in the intensive care unit.
- Trial name
- NCT01848158
- Testing
- acupuncture
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Seattle Children's Hospital
Intensive Care Units, Pediatric, Anesthetics, Inhalation
Advancing Brain Outcomes in Pediatric Critically Ill Patients Sedated With Volatile AnEsthestic Agents
The goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. This study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce…
- Conditions
- Intensive Care Units, Pediatric, Anesthetics, Inhalation, Mechanically Ventilated, Critically Ill Children
- Trial name
- ABOVE (NCT05867472)
- Testing
- Isoflurane Inhalant Product
- Where
- 3 sites in Canada
- Volunteers
- 60 people
- Sponsor
- Sunnybrook Health Sciences Centre
Sedated ICU Patients
IMPROVE Critical Care Study (Pilot)
The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management.
- Trial name
- NCT01361230
- Testing
- "Sedation Trial Monitor" is the name of the device used.
- Where
- United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GE Healthcare