DEX vs SEVO in Congenital Heart Surgery

NCT ID: NCT05369949

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2026-06-30

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.

Conditions

Heart Defects, Congenital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DEX group

Participants will receive an intraoperative and postoperative DEX infusion. In addition a low dose of sevoflurane will be administered.

Group Type: EXPERIMENTAL

DEX group

Intervention Type: DRUG

Participants will receive a dexmedetomidine infusion in addition to low dose sevoflurane anesthesia.

Control group

Participants will receive general anesthesia with sevoflurane according to institutinal's practice.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Participants will receive general anesthesia based on institutional's practice with commonly used doses of sevoflurane.

Interventions

DEX group

Participants will receive a dexmedetomidine infusion in addition to low dose sevoflurane anesthesia.

Intervention Type: DRUG

Control group

Participants will receive general anesthesia based on institutional's practice with commonly used doses of sevoflurane.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Mona Momeni, MD, PhD

Deputy Anesthesiologist in Chief. MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Momeni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Central Contacts

Mona Momeni, MD, PhD

Role: CONTACT

mona.momeni@uclouvain.be

003227647029

Other Identifiers

Ethical Advice

Identifier Type: -

Identifier Source: org_study_id