Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI

Condition(s) targeted: Delirium on Emergence

Intervention: Propofol (Drug); Propofol (Drug); Sevoflurane (Drug); Isoflurane (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: State University of New York at Buffalo

Official(s) and/or principal investigator(s):
Jerrold Lerman, MD, Principal Investigator, Affiliation: Women And Childrens Hospital Of Buffalo
Christopher Heard, MD, Principal Investigator, Affiliation: Women And Childrens Hospital Of Buffalo

Overall contact:
Jerrold Lerman, M.D, FRCPC, Phone: 716-878-7701, Email: jlerman@buffalo.edu

Children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. This occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. However, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during MRI to obviate the contribution of pain during emergence. Airway complications have been reported after LMA and isoflurane more commonly than with IV propofol and nasal prongs. Whether the airway complications were due to the LMA or the isoflurane was unclear. Therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with IV propofol and 2. airway complications after LMA or nasal prongs.

Official title: Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI: Comparative Study Using Propofol, Sevoflurane and Isoflurane

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of delirium on emergence

Secondary outcome: Incidence of airway complications

Detailed description: 180 children, ASA physical status 1 or 2 will be recruited for elective MRI scan. Randomized after consent is obtained to one of four groups. Anxiety will be assessed preoperatively using the modified Yale preoperative anxiety scale. Children will be accompanied by one parent to MRI scanner where monitors are applied. All children will have anesthesia induced with nitrous oxide and oxygen followed by sevoflurane until IV is established. Thereupon, they will be managed by their randomization assignment. The propofol pump will be concealed at all times. If propofol was used, it will be disconnected from the patient and residual propofol in the line flushed so prevent unblinding the patient's assignment. A blinded observer will be present to evaluate the patient when emergence begins. The single blinded observer will follow the patient from the MRI scanner through recovery room evaluating vital signs as well as emergence delirium (using the PAED scale). A PAED score > 12 at any time during emergence period will confirm the diagnosis of emergence delirium. After discharge from hospital, a post-discharge questionnaire will be completed at 12, 24 and 48 hours after discharge. All parents will be called to retrieve the questionnaire results after 48 hours after discharge from hospital.

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 2-12yrs,

- ASA Class I-II,

- Fasting,

- Unmedicated,

- Elective MRI scan

Exclusion Criteria:

- Cognitive impairment,

- On psychotropic medications,

- Taking multiple (>2) antiepileptic medications,

- Requiring endotracheal intubation for GA

Jerrold Lerman, M.D, FRCPC, Phone: 716-878-7701, Email: jlerman@buffalo.edu

Women and Chidren's Hospital Of Buffalo, Buffalo, New York 14222, United States; Recruiting
Jerrold Lerman, M.D, FRCPC, Phone: 716-878-7701, Email: jlerman@buffalo.edu
Chistopher Heard, M.D, Phone: 716-878-7701, Email: gazzzman13@gmail.com
Jerrold Lerman, MD, Principal Investigator
Christopher Heard, MD, Principal Investigator
Rajeshri Asariparampil, M.B.B.S, M.D, Sub-Investigator
Tamer Elattary, M.D, Sub-Investigator
Rafeek Hegazy, M.D, Sub-Investigator

Starting date: January 2014
Last updated: April 9, 2014