None listed
Conditions
Brief summary
Intravenous sedatives and analgesics are commonly administered to mechanically ventilated children post cardiac surgery, however there is substantial variability in sedation practices in different intensive care units and in different countries around the world. The Cardiac BabySPICE pilot study will evaluate the hypothesis that early light sedation with dexmedetomidine reduces length of mechanical ventilation and length of stay in PICU compared to standard practice (midazolam). In addition we will follow up the neurodevelopment (at 6 and 12 months) of the included subjects; infants undergoing cardiac surgery on bypass <6 months of age. The purpose of the Cardiac BabySPICE Pilot RCT is to obtain preliminary data on the feasibility and safety of conducting a study that tests this hypothesis. This is a pilot prospective randomised controlled trial that will be conducted in the Lady Cilento Children's Hospital paediatric intensive care unit in Australia and will recruit 60 patients. The study will recruit patients undergoing repair of congenital heart disease who require a breathing tube at least 24 hours after enrolment AND need immediate and ongoing sedation. Patients will be recruited into one of 2 study groups. The study drug will commence whilst the child is in surgery. The intervention arm will receive dexmedetomidine as the primary agent, with the addition of secondline sedatives as required by infusion, boluses or both. The use of benzodiazepines in this arm will be minimized and clonidine will not be used concurrently with dexmedetomidine. The control arm will have midazolam according to usual practice.In both groups, the default sedation level in PICU is light sedation, as defined by a target State Behaviour Scale (SBS) of 1 to +1, unless otherwise specified by the treating clinician. The primary outcome measure for the pilot study is to demonstrate separation between the intervention group (Dex) and the control group (Mid) with respect to the proportion of patients achieving light sedation (SBS 1 to +1) in the first 48 hours of sedation in intensive care.WE will also examine length of veniltation, PICU length of stay and long term outcomes. Information from the Pilot RCT will be used to design a subsequent phase III trial.
Interventions
Intravenous infusion of Dexmedetomidine 1mcg/kg/hr commenced at sternotomy for the duration of the surgical procedure and during mechanical ventilation in the paediatric intensive care.
Sponsors
Paediatic Critical Care Research Group
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 12 Months
Healthy volunteers
No
Inclusion criteria
1. The patient is undergoing surgical repair of a congenital heart defect requiring cardiopulmonary bypass and will require mechanical ventilation via an endotracheal tube post-operatively, and the treating clinician believes that: 2. The patient will require immediate post-operative AND ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures. 3. The patient is expected to remain intubated post-operatively.
Exclusion criteria
1. Age > 12 months 2. Proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, intracranial infection or hypoxic brain injury. 3. Allergy to dexmedetomidine
Outcome results
None listed