Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03882788
Other study ID # NDO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 22, 2013
Est. completion date November 19, 2020

Study information

Verified date May 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 18-48 months.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date November 19, 2020
Est. primary completion date November 19, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 36 Months
Eligibility 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

Study Design


Intervention

Drug:
Isoflurane
Isoflurane (volatile anesthesia) will be delivered at 1.5-2.0%% as required for anesthetic management.
Fentanyl (high dose)
Fentanyl (narcotic anesthesia) maintenance will be with fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr.
Fentanyl (low dose)
Fentanyl (narcotic anesthesia) maintenance will be with fentanyl 2 mcg/kg/hr.

Locations

Country Name City State
United States Stanford Childrens hospital Palo Alto California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bayley III Neurodevelopmental assessment scores are age dependent and based motor and behavioral abilities, often reported for normal or abnormal for age. Bayley Scales of Infant and Toddler Development, third edition, (Bayley III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items, score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Assessed once between age 18 to 48 months (approximately 2 hours to assess), up to 48 months from study start
Primary Electroencephalogram Brain electrical activity: observation is for brain region specific abnormal or seizure activity. Number of participants with abnormal EEG are reported. EEG taken immediately prior to surgery, during surgery, during cardiovascular intensive care unit (CVICU) stay (up to 48 hours after surgery), and immediately prior to discharge (between 5 to 20 minutes to assess EEG at each time point)
Secondary Choline blood levels: time and patient dependent variation, observed patient related trends over time 0-72 hours
Secondary Glutamate blood levels:time and patient dependent variation, observed patient related trends over time 0-72 hours
Secondary N-acetylaspartate (Naa) blood levels:time and patient dependent variation, observed patient related trends over time 0-72 hours
Secondary Lactate blood levels:time and patient dependent variation, observed patient related trends over time 0-72 hours
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04992793 - Paediatric Brain Injury Following Cardiac Interventions
Recruiting NCT05213598 - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed NCT04136379 - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed NCT04814888 - 3D Airway Model for Pediatric Patients
Recruiting NCT04920643 - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery N/A
Completed NCT05934578 - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training N/A
Recruiting NCT06041685 - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia N/A
Recruiting NCT05902013 - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation N/A
Not yet recruiting NCT05687292 - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting NCT05524324 - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT N/A
Completed NCT02746029 - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed NCT03119090 - Fontan Imaging Biomarkers (FIB) Study
Completed NCT02537392 - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease N/A
Recruiting NCT02258724 - Swiss National Registry of Grown up Congenital Heart Disease Patients
Terminated NCT02046135 - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery Phase 2
Completed NCT01966237 - Milrinone Pharmacokinetics and Acute Kidney Injury
Recruiting NCT01184404 - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery N/A
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A