A Study to Compare the Long-term Outcomes After Two Different Anaesthetics
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anesthesia
- Child Development
- Neurotoxicity
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomised to receive either low-dose sevoflurane/dexmedetomidine/remifentanil OR standard dose sevoflurane anaesthesia.Masking: Single (Outcomes Assessor)Masking Description: Randomisation 1:1 will be stratified by site and age at exposure (less than 12 months and greater than or equal to 12 months). Randomisation will be in blocks of variable size. The treating anaesthetist will not be blinded to treatment arm. The assessing neuropsychologist and parents will be blinded to treatment arm.Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 2 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03089905
- Collaborators
- Sydney Children's Hospitals Network
- Baylor College of Medicine
- Boston Children's Hospital
- The Cleveland Clinic
- University of Texas, Southwestern Medical Center at Dallas
- Royal Children's Hospital, Melbourne
- Flinders Medical Centre
- Children's Hospital of Philadelphia
- Queensland Children's Hospital
- Perth Children's Hospital
- Women's and Children's Hospital, Adelaide
- Istituto Giannina Gaslini, Genoa, Italy
- Investigators
- Study Chair: Andrew J Davidson, MD Royal Children's Hospital, Melbourne
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