Clinical trial NCT02111447: Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
Official title: Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI: Comparative Study Using Propofol, Sevoflurane and Isoflurane
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Delirium on Emergence
Keywords: children
sevoflurane
isoflurane
propofol
anesthesia
MRI
delirium
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 6
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Incidence of Delirium on Emergence
timeFrame: WIthin 2 hours of emergence from anesthesia
Secondary outcomes:
measure: Incidence of Airway Complications
timeFrame: WIthin 2 hours of emergence from anesthesia
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Women and Chidren's Hospital Of Buffalo
state: New York
Study officials:
affiliation: Women And Childrens Hospital Of Buffalo
name: Jerrold Lerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women And Childrens Hospital Of Buffalo
name: Christopher Heard, MD
role: PRINCIPAL_INVESTIGATOR
References: