Study Stopped
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Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 9, 2014
CompletedFirst Posted
Study publicly available on registry
April 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
July 23, 2019
CompletedJuly 23, 2019
July 1, 2019
11 months
April 9, 2014
April 4, 2019
July 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of Airway Complications
WIthin 2 hours of emergence from anesthesia
Study Arms (4)
Sevoflurane, propofol, Nasal oxygen
ACTIVE COMPARATORAfter securing the IV, sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. A bolus of propofol will not be administered. Oxygen will be delivered via nasal prongs at 2 liters per minute. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min also after 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be administered if the child moves or if signs of light anesthesia are noticed. The propofol infusion may also be increased in response to light anesthesia.
Sevoflurane, Propofol, LMA
ACTIVE COMPARATORAfter securing the IV, weight appropriate LMA will be inserted and sevoflurane will be discontinued and a propofol infusion will be started at the dose of 300 mcg/kg/min depending on the child's age and neurologic status. Oxygen in air will be delivered via LMA. The infusion rate of propofol will be decreased to 250 after 15 min and then 200 mcg/kg/min after another 15 min. Supplemental IV boluses of Propofol (0.5 mg/kg) will be given if the child moves or exhibits signs of light anesthesia. The propofol infusion may also be increased in response to light anesthesia.
Sevoflurane, sevoflurane, LMA
ACTIVE COMPARATORAfter securing the IV, weight appropriate LMA will be inserted and sevoflurane continued at 3% inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. The sevoflurane may be increased or decreased in 0.5% increments as needed.
Sevoflurane, isoflurane, LMA
ACTIVE COMPARATORAfter securing the IV, weight appropriate LMA will be inserted , sevoflurane will be discontinued and isoflurane will be administered at 2 % inspired concentration. Oxygen in air will be delivered via LMA at 2 lpm. Isoflurane may be increased or decreased in 0.5% increments as needed.
Interventions
Propofol infusion with nasal oxygen
Sevoflurane with an LMA
Eligibility Criteria
You may qualify if:
- Age 2-12yrs,
- ASA Class I-II,
- Fasting,
- Unmedicated,
- Elective MRI scan
You may not qualify if:
- Cognitive impairment,
- On psychotropic medications,
- Taking multiple (\>2) antiepileptic medications,
- Requiring endotracheal intubation for GA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women and Chidren's Hospital Of Buffalo
Buffalo, New York, 14222, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
none study not completed due to facility issues
Results Point of Contact
- Title
- Research Coordinator
- Organization
- GLA
Study Officials
- PRINCIPAL INVESTIGATOR
Jerrold Lerman, MD
Women And Childrens Hospital Of Buffalo
- PRINCIPAL INVESTIGATOR
Christopher Heard, MD
Women And Childrens Hospital Of Buffalo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor of Anesthesiology
Study Record Dates
First Submitted
April 9, 2014
First Posted
April 11, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 23, 2019
Results First Posted
July 23, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share