DEX vs SEVO in Congenital Heart Surgery

Heart Defects, Congenital Clinical Trial

— DEXLOSNeuro  

Official title:

Effect of DEXmedetomidine and LOw Dose Sevoflurane on the Release of Serum Neurofilament Light in Congenital Cardiac Surgery.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05369949
• Other study ID #: Ethical Advice
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 5, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2022
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Mona Momeni, MD, PhD
• Phone: 003227647029
• Email: mona.momeni[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Drug:
• DEX group
Participants will receive a dexmedetomidine infusion in addition to low dose sevoflurane anesthesia.

Other:
• Control group
Participants will receive general anesthesia based on institutional's practice with commonly used doses of sevoflurane.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of serum Neurofilament Light	To show a difference of change in serum NfL concentrations between both groups at 24h compared to baseline values.	At 24 hours postoperatively
Secondary	Concentration of serum Neurofilament Light		Baseline before start of anesthesia
Secondary	Concentration of serum Neurofilament Light		Start of cardiopulmonary bypass
Secondary	Concentration of serum Neurofilament Light		At 72 hours postoperatively
Secondary	Concentration of serum Neurofilament Light		At postoperative day 5
Secondary	Neurodevelopmental outcome testing	Bailey Scales of Infant and Toddler Development - Third Edition. Higher scores are better.	3 months postoperatively
Secondary	Neurodevelopmental outcome testing	Bailey Scales of Infant and Toddler Development - Third Edition. Higher scores are better.	6 months postoperatively
Secondary	Postoperative electroencephalogram registration	Number of seizures	24 hours
Secondary	Dose of Analgesics	Use and dose of analgesics	72 hours postoperatively
Secondary	Renal function	Defined by pediatric RIFLE criteria	7 days postoperatively
Secondary	Concentration of regional cerebral oxygenation	Area Under Curve of time spent below rSO2 levels of 50%; Area Under Curve of time spent below baseline rSO2 levels	Intraoperatively
Secondary	Postoperative electroencephalogram registration	Number of burst-suppression episodes	24 hours
Secondary	Postoperative electroencephalogram registration	Duration of burst-suppression episodes	24 hours
Secondary	Postoperative electroencephalogram registration	Duration of seizures	24 hours
Secondary	Time of exsudation	time to extubation	7 days postoperatively
Secondary	Pediatric Intensive Care Unit stay	Duration of stay in Pediatric Intensive Care Unit	Up to 24 weeks
Secondary	Hospital stay	Days of hospital stay	Up to 24 weeks