Sedation Practice in Paediatric Intensive Care Cardiac Patients: Cardiac Baby SPICE -pilot randomised trial

Phase 2

Completed

• Conditions: Congenital cardiac defects requiring surgical repair; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Anaesthesiology - Anaesthetics; Surgery - Other surgery

• Registration Number: ACTRN12615001304527
• Lead Sponsor: Paediatic Critical Care Research Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-30
• Study Completion: 2020-12-30
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified