DEX vs SEVO in Congenital Heart Surgery

NCT05369949 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Ethical Advice
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Concentration of serum Neurofilament Light

  Baseline before start of anesthesia

• Concentration of serum Neurofilament Light

  Start of cardiopulmonary bypass

• Concentration of serum Neurofilament Light

  At 72 hours postoperatively

• Concentration of serum Neurofilament Light

  At postoperative day 5

• Neurodevelopmental outcome testing

  3 months postoperatively

Study Arms (2)

DEX group

EXPERIMENTAL

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

Drug: DEX group

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

DEX group DRUG

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

DEX group

Control group OTHER

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

Control group

Eligibility Criteria

• Age: 1 Day - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mona Momeni, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Momeni, MD, PhD

CONTACT

003227647029; mona.momeni@uclouvain.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The patient's parents will be informed of the study allocation in case they wish to know this, otherwise they are not supposed to be aware of group allocation. Persons who will assess the neurodevelopment outcome will not be aware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Anesthesiologist in Chief. MD,PhD

Model Details: The Intervention Drug is DEXMEDETOMIDINE

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 11, 2022
• Study Start: January 5, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 23, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share