Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia

Participants:

Patients with a structurally normal heart scheduled to undergo elective electrophysiology study with catheter ablation of an arrhythmia under general anesthesia were recruited. Forty one patients were enrolled from October 2016 to March 2020. Written informed consent was obtained from the participants or their respective parents/guardians before the study and written assent was obtained from children ≥7 years of age. All study procedures were approved by the Institutional Review Board (IRB-P00021030) of Boston Children's Hospital, Boston, Massachusetts and the study registered with clinicaltrials.gov (NCT02703090).

Randomization, Allocation concealment and blinding:

The hospital research pharmacy used a parallel group design, with block randomization to allocate the patients into either high-dose, low-dose or placebo groups. The clinical staff, research personnel and the patients were unaware of the drug allocated to a particular patient (double-blinded). The decision to unblind was made by the principal investigators (B.K and D.B) and performed by the pharmacy after all the data were acquired, preprocessed and were ready for group level statistical analysis.

Power Analysis: