Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02111447
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 4
• Duration (Months): 11
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium on Emergence	Drug: Propofol; Drug: Propofol; Drug: Sevoflurane; Drug: Isoflurane	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI: Comparative Study Using Propofol, Sevoflurane and Isoflurane
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sevoflurane, propofol, Nasal oxygen 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.	Drug: Propofol; Propofol infusion with nasal oxygen; Other Names: Diprivan 1% ; Drug: Propofol; Propofol infusion with an LMA; Other Names: 1% Diprivan
Active Comparator: Sevoflurane, Propofol, LMA 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.	Drug: Propofol; Propofol infusion with nasal oxygen; Other Names: Diprivan 1% ; Drug: Sevoflurane; Sevoflurane with an LMA; Other Names: Sevorane
Active Comparator: Sevoflurane, sevoflurane, LMA 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.	Drug: Sevoflurane; Sevoflurane with an LMA; Other Names: Sevorane
Active Comparator: Sevoflurane, isoflurane, LMA 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.	Drug: Sevoflurane; Sevoflurane with an LMA; Other Names: Sevorane ; Drug: Isoflurane; Isoflurane with an LMA; Other Names: Forane

Outcome Measures

Primary Outcome Measures

1. Incidence of Delirium on Emergence [WIthin 2 hours of emergence from anesthesia]

   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

1. Incidence of Airway Complications [WIthin 2 hours of emergence from anesthesia]

   All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation <92% for >15 s regardless of the cause, bronchospasm, secretions and hiccups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women and Chidren's Hospital Of Buffalo	Buffalo	New York	United States	14222

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

• Principal Investigator: Jerrold Lerman, MD, Women And Childrens Hospital Of Buffalo
• Principal Investigator: Christopher Heard, MD, Women And Childrens Hospital Of Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jerrold Lerman, Clinical Professor of Anesthesiology, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT02111447
• Other Study ID Numbers: 412889-6
• First Posted: Apr 11, 2014
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jerrold Lerman, Clinical Professor of Anesthesiology, State University of New York at Buffalo: children; sevoflurane; isoflurane; propofol; anesthesia; MRI; delirium
• Additional relevant MeSH terms: Delirium; Emergence Delirium; Propofol; Sevoflurane; Isoflurane

Study Results

Participant Flow

Arm/Group Title	Sevoflurane, Propofol, Nasal Oxygen	Sevoflurane, Propofol, LMA	Sevoflurane, Sevoflurane, LMA	Sevoflurane, Isoflurane, LMA
Arm/Group 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. Propofol: Propofol infusion with nasal oxygen Propofol: Propofol infusion with an LMA	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. Propofol: Propofol infusion with nasal oxygen Sevoflurane: Sevoflurane with an LMA	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. Sevoflurane: Sevoflurane with an LMA	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. Sevoflurane: Sevoflurane with an LMA Isoflurane: Isoflurane with an LMA
Period Title: Overall Study
STARTED	0	5	1	0
COMPLETED	0	5	1	0
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Sevoflurane, Propofol, Nasal Oxygen	Sevoflurane, Propofol, LMA	Sevoflurane, Sevoflurane, LMA	Sevoflurane, Isoflurane, LMA	Total
Arm/Group 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. Propofol: Propofol infusion with nasal oxygen Propofol: Propofol infusion with an LMA	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. Propofol: Propofol infusion with nasal oxygen Sevoflurane: Sevoflurane with an LMA	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. Sevoflurane: Sevoflurane with an LMA	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. Sevoflurane: Sevoflurane with an LMA Isoflurane: Isoflurane with an LMA	Total of all reporting groups
Overall Participants	0	5	1	0	6
Age (Count of Participants)
<=18 years	0 NaN	5 100%	1 100%	0 NaN	6 100%
Between 18 and 65 years	0 NaN	0 0%	0 0%	0 NaN	0 0%
>=65 years	0 NaN	0 0%	0 0%	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	3 Infinity	0 0%	3 300%
Male	2 Infinity	1 20%	3 300%
Region of Enrollment (participants) [Number]
United States	5 Infinity	1 20%	6 600%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

none recruited that that group

Arm/Group Title	Sevoflurane, Propofol, Nasal Oxygen	Sevoflurane, Sevoflurane, LMA	Sevoflurane, Propofol, LMA	Sevoflurane, Isoflurane, LMA
Arm/Group 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. Propofol: Propofol infusion with nasal oxygen Propofol: Propofol infusion with an LMA	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. Sevoflurane: Sevoflurane with an LMA	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. Propofol: Propofol infusion with nasal oxygen Sevoflurane: Sevoflurane with an LMA	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. Sevoflurane: Sevoflurane with an LMA Isoflurane: Isoflurane with an LMA
Measure Participants	0	1	5	0
Count of Participants [Participants]	0 NaN	1 20%	5 500%	0 NaN

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

none recruited to that group

Arm/Group Title	Sevoflurane, Propofol, Nasal Oxygen	Sevoflurane, Sevoflurane, LMA	Sevoflurane, Propofol, LMA	Sevoflurane, Isoflurane, LMA
Arm/Group 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. Propofol: Propofol infusion with nasal oxygen Propofol: Propofol infusion with an LMA	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. Sevoflurane: Sevoflurane with an LMA	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. Propofol: Propofol infusion with nasal oxygen Sevoflurane: Sevoflurane with an LMA	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. Sevoflurane: Sevoflurane with an LMA Isoflurane: Isoflurane with an LMA
Measure Participants	0	1	5	0
Count of Participants [Participants]	0 NaN	1 20%	5 500%	0 NaN

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	Definition does not differ.
Arm/Group Title	Sevoflurane, Propofol, Nasal Oxygen		Sevoflurane, Sevoflurane, LMA		Sevoflurane, Propofol, LMA		Sevoflurane, Isoflurane, LMA
Arm/Group 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. Propofol: Propofol infusion with nasal oxygen Propofol: Propofol infusion with an LMA		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. Sevoflurane: Sevoflurane with an LMA		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. Propofol: Propofol infusion with nasal oxygen Sevoflurane: Sevoflurane with an LMA		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. Sevoflurane: Sevoflurane with an LMA Isoflurane: Isoflurane with an LMA
All Cause Mortality
	Sevoflurane, Propofol, Nasal Oxygen		Sevoflurane, Sevoflurane, LMA		Sevoflurane, Propofol, LMA		Sevoflurane, Isoflurane, LMA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)		0/5 (0%)		0/0 (NaN)
Serious Adverse Events
	Sevoflurane, Propofol, Nasal Oxygen		Sevoflurane, Sevoflurane, LMA		Sevoflurane, Propofol, LMA		Sevoflurane, Isoflurane, LMA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)		0/5 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Sevoflurane, Propofol, Nasal Oxygen		Sevoflurane, Sevoflurane, LMA		Sevoflurane, Propofol, LMA		Sevoflurane, Isoflurane, LMA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)		0/5 (0%)		0/0 (NaN)

Limitations/Caveats

none study not completed due to facility issues

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.