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Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI

Primary Purpose

Delirium on Emergence

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propofol
Propofol
Sevoflurane
Isoflurane
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium on Emergence focused on measuring children, sevoflurane, isoflurane, propofol, anesthesia, MRI, delirium

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Women and Chidren's Hospital Of Buffalo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sevoflurane, propofol, Nasal oxygen

Sevoflurane, Propofol, LMA

Sevoflurane, sevoflurane, LMA

Sevoflurane, isoflurane, LMA

Arm Description

After 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.

After 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.

After 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.

After 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 9, 2014
Last Updated
July 1, 2019
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT02111447
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Not enough participants
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium on Emergence
Keywords
children, sevoflurane, isoflurane, propofol, anesthesia, MRI, delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane, propofol, Nasal oxygen
Arm Type
Active Comparator
Arm Description
After 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.
Arm Title
Sevoflurane, Propofol, LMA
Arm Type
Active Comparator
Arm Description
After 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.
Arm Title
Sevoflurane, sevoflurane, LMA
Arm Type
Active Comparator
Arm Description
After 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.
Arm Title
Sevoflurane, isoflurane, LMA
Arm Type
Active Comparator
Arm Description
After 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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan 1%
Intervention Description
Propofol infusion with nasal oxygen
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
1% Diprivan
Intervention Description
Propofol infusion with an LMA
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevorane
Intervention Description
Sevoflurane with an LMA
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Other Intervention Name(s)
Forane
Intervention Description
Isoflurane with an LMA
Primary Outcome Measure Information:
Title
Incidence of Delirium on Emergence
Description
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.
Time Frame
WIthin 2 hours of emergence from anesthesia
Secondary Outcome Measure Information:
Title
Incidence of Airway Complications
Description
All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation <92% for >15 s regardless of the cause, bronchospasm, secretions and hiccups
Time Frame
WIthin 2 hours of emergence from anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold Lerman, MD
Organizational Affiliation
Women And Childrens Hospital Of Buffalo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Heard, MD
Organizational Affiliation
Women And Childrens Hospital Of Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women and Chidren's Hospital Of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI

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