The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/22/2019 |
| Start Date: | April 22, 2013 |
| End Date: | December 1, 2020 |
Anesthesia and the Developing Brain: a Comparison of Two Anesthetic Techniques
The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus
inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes
to the wide variation in neurologic recovery and developmental outcome after surgery in
infants with congenital heart disease.
inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes
to the wide variation in neurologic recovery and developmental outcome after surgery in
infants with congenital heart disease.
All subjects will be consented prior to participation in this study and prior to
randomization.
All the subjects enrolled in the study will receive a preoperative assessment by one of the
cardiac anesthesiologists and receive standardized induction with sevoflurane up to 2%, 2
mcg/kg of fentanyl and 1 mg/kg of rocuronium. The anesthetic maintenance will be determined
using a computer- generated randomization table and assigning each patient to one of the two
anesthetic regimens. Both of these anesthetic techniques are standard of care and are
commonly used for these procedures.
Anesthetic Technique:
Volatile anesthetic:
In volatile anesthetic technique, maintenance of anesthesia will be standardized to the
volatile anesthetic isoflurane. Isoflurane will be used for the study since this is what is
presently available on the CPB machines. Anesthesia at 1.0 minimum anesthetic concentration
(MAC) indicates that at this concentration 50% of the patients will not move when surgically
stimulated. Anesthesiologists commonly use about 1.2-1.4 MAC in neonates, since the MAC value
in infants is higher than that of children and adults. Isoflurane will be delivered at
1.5-2.0%% as required for anesthetic management.
Rocuronium or pancuronium will be used for muscle relaxation. Narcotic, fentanyl will be
administered at no greater than 2 mcg/kg/hr.
Narcotic-based anesthetic:
In narcotic based anesthetic technique, no volatile anesthetics will be used except during
induction.
Maintenance of anesthesia will be with fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr.
The anesthetic may be supplemented with dexmedetomidine 0.05 mcg/kg/hr but not to exceed 1.0
mcg/kg/hr. Narcotic-based anesthetic will be used by the cardiac anesthesia team and the CPB
technician throughout the operative case. 5 mcg/kg/hr of fentanyl is felt to represent 0.6
MAC of anesthesia.
Postoperative Sedative and Analgesic Care:
As per institutional standard of care, postoperative sedation will consist of fentanyl
infusions of 2-4 mcg/kg/hr for the first 48 hours postoperatively.
A total of 9 Blood samples will be collected at different time points throughout the entire
study for metabolomics determination (NAA/Cr and Chol/Cr)
EEG monitoring will be done for baseline in the pre-operative period for 15-20 minutes,
during surgery and post-operatively up to 48 hours and prior to discharge for 15-20 minutes.
Neurological and behavioral testing including Bayley Exam III will be done at 12-48 months.
randomization.
All the subjects enrolled in the study will receive a preoperative assessment by one of the
cardiac anesthesiologists and receive standardized induction with sevoflurane up to 2%, 2
mcg/kg of fentanyl and 1 mg/kg of rocuronium. The anesthetic maintenance will be determined
using a computer- generated randomization table and assigning each patient to one of the two
anesthetic regimens. Both of these anesthetic techniques are standard of care and are
commonly used for these procedures.
Anesthetic Technique:
Volatile anesthetic:
In volatile anesthetic technique, maintenance of anesthesia will be standardized to the
volatile anesthetic isoflurane. Isoflurane will be used for the study since this is what is
presently available on the CPB machines. Anesthesia at 1.0 minimum anesthetic concentration
(MAC) indicates that at this concentration 50% of the patients will not move when surgically
stimulated. Anesthesiologists commonly use about 1.2-1.4 MAC in neonates, since the MAC value
in infants is higher than that of children and adults. Isoflurane will be delivered at
1.5-2.0%% as required for anesthetic management.
Rocuronium or pancuronium will be used for muscle relaxation. Narcotic, fentanyl will be
administered at no greater than 2 mcg/kg/hr.
Narcotic-based anesthetic:
In narcotic based anesthetic technique, no volatile anesthetics will be used except during
induction.
Maintenance of anesthesia will be with fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr.
The anesthetic may be supplemented with dexmedetomidine 0.05 mcg/kg/hr but not to exceed 1.0
mcg/kg/hr. Narcotic-based anesthetic will be used by the cardiac anesthesia team and the CPB
technician throughout the operative case. 5 mcg/kg/hr of fentanyl is felt to represent 0.6
MAC of anesthesia.
Postoperative Sedative and Analgesic Care:
As per institutional standard of care, postoperative sedation will consist of fentanyl
infusions of 2-4 mcg/kg/hr for the first 48 hours postoperatively.
A total of 9 Blood samples will be collected at different time points throughout the entire
study for metabolomics determination (NAA/Cr and Chol/Cr)
EEG monitoring will be done for baseline in the pre-operative period for 15-20 minutes,
during surgery and post-operatively up to 48 hours and prior to discharge for 15-20 minutes.
Neurological and behavioral testing including Bayley Exam III will be done at 12-48 months.
Inclusion Criteria:
- Neonates of at least 32 weeks of gestation, infants and children up to 2 years of age
admitted to The Children's Hospital for treatment of cyanotic or non-cyanotic heart
disease requiring surgical intervention.
- Admitting diagnosis of cyanotic or non-cyanotic heart disease
Exclusion Criteria:
- Neonates less than 32 weeks of gestational age, and children more than 2 years of age.
- Any documented central nervous system malformations.
- Any potential subject requiring unexpected postoperative Extracorporeal membrane
oxygenation (ECMO) support
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