Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI

Delirium on Emergence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02111447
• Other study ID #: 412889-6
• Status: Terminated
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2019
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Delirium on Emergence
• Emergence Delirium
• Problem Behavior

Intervention

Drug:
• Propofol
Propofol infusion with nasal oxygen
• Propofol
Propofol infusion with an LMA
• Sevoflurane
Sevoflurane with an LMA
• Isoflurane
Isoflurane with an LMA

Locations

Country	Name	City	State
United States	Women and Chidren's Hospital Of Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Delirium on Emergence	Delirium on emergence will be assessed using the PAED scale by a blinded observer in the post anesthesia period. A score >12 constitutes a diagnosis of delirium in children. The post anesthesia period is usually <2 hours after anesthesia.	WIthin 2 hours of emergence from anesthesia
Secondary	Incidence of Airway Complications	All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation <92% for >15 s regardless of the cause, bronchospasm, secretions and hiccups	WIthin 2 hours of emergence from anesthesia