Medical Student Research Fellowship for Summer 2011
Mentor: Peter Szmuk
Department: Anesthesiology and Pain Management
Room number: B 3304 @ CMC
Phone number: 214 456 6393
Project title: The GAS study, A multi-site, randomized controlled trial comparing reginal and general anesthesia for effects on neurodevelopmental outcome and apnea in infants.
Human subjects IRB approved project number (where applicable):
Animal subjects IRB approved project number (where applicable):
Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects)
Brief Description of Project:
Objectives: The primary objective of this trial is to determine whether different types of anaesthesia [regional versus general] given to infants undergoing inguinal hernia repair result in equivalent neurodevelopmental outcomes. Secondary objectives are to describe the frequency and characteristics of apnoea in the post-operative period after both regional and general anaesthesia for inguinal hernia repair in infants, and determine the factors associated with apnoea.
Study population: 660 infants of postmenstrual age 60 weeks age or less, scheduled for inguinal hernia repair under anaesthesia. Exclusion criteria include recognised risk factors for adverse neurodevelopmental outcome or previous exposure to general anaesthesia. Infants born at less than 26 weeks gestation will be excluded.
Design: Prospective, observer blind, multi-site, randomised, controlled, equivalence trial.
Treatment groups: The general anaesthesia group will receive sevoflurane for maintenance and induction. The airway can be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents. Analgesia can be supplied with a caudal or ilioinguinal nerve block with bupivacaine up to a maximum dose of 2.5 mg/kg.
The regional group will have no sedative agents. The regional blockade may be with spinal block alone, spinal block with caudal block, spinal with ilioinguinal block or caudal alone. A maximum dose of 2.5 mg/kg of bupivacaine can be used.
Outcome measure: Neurodevelopmental assessments will occur at 2 and 5 years with standard neuropsychological tools. Apnoea events and interventions for apnoea will also be recorded.
Primary outcome: The primary outcome will be the WPPSI-III Full Scale IQ score at 5 years corrected age
The student’s specific role: The student will help identifying the patient, participating in the consent process along the PI, recording data during and after the anesthesia and following up with the patients. If time permits, the student is encourage to participate in the 2 year postoperative neurodevelopmental assessment.
Previous Research Activities or Publications with Medical Students:
Landon Farris, 2010