DEX vs SEVO in Congenital Heart Surgery

Phase 4

Not yet recruiting

• Conditions: Heart Defects, Congenital
• Interventions: Other: Control group; Drug: DEX group

• Registration Number: NCT05369949
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT).

Animal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-23
• Study Start: 2023-01-05
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients up to 3 years
• Must undergo cardiac surgery with CPB

Exclusion Criteria

• Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml/min per 1.73m2 for greater than 3 months)
• Preoperative cerebral hemorrhage, stroke or
• Preoperative seizures
• Abnormal preoperative cerebral ultrasound
• Preoperative Extracorporeal Life Support
• Preoperative sedated and intubated patients
• Preterm newborns (< 32 W gestational age)
• Newborns weighing < 2 kg
• Patients with Williams-Beuren syndrome.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	Participants will receive general anesthesia with sevoflurane according to institutinal's practice.
DEX group	DEX group	Participants will receive an intraoperative and postoperative DEX infusion. In addition a low dose of sevoflurane will be administered.

Primary Outcome Measures

Name	Time	Method
Concentration of serum Neurofilament Light	At 24 hours postoperatively	To show a difference of change in serum NfL concentrations between both groups at 24h compared to baseline values.

Secondary Outcome Measures

Name	Time	Method
Renal function	7 days postoperatively	Defined by pediatric RIFLE criteria
Hospital stay	Up to 24 weeks	Days of hospital stay
Concentration of serum Neurofilament Light	At postoperative day 5
Dose of Analgesics	72 hours postoperatively	Use and dose of analgesics
Time of exsudation	7 days postoperatively	time to extubation
Neurodevelopmental outcome testing	6 months postoperatively	Bailey Scales of Infant and Toddler Development - Third Edition. Higher scores are better.
Postoperative electroencephalogram registration	24 hours	Duration of seizures
Concentration of regional cerebral oxygenation	Intraoperatively	Area Under Curve of time spent below rSO2 levels of 50%; Area Under Curve of time spent below baseline rSO2 levels
Pediatric Intensive Care Unit stay	Up to 24 weeks	Duration of stay in Pediatric Intensive Care Unit