Trial Outcomes & Findings for Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI (NCT NCT02111447)
NCT ID: NCT02111447
Last Updated: 2019-07-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
WIthin 2 hours of emergence from anesthesia
Results posted on
2019-07-23
Participant Flow
Participant milestones
| Measure |
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.
Propofol: Propofol infusion with nasal oxygen
Propofol: Propofol infusion with an LMA
|
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.
Propofol: Propofol infusion with nasal oxygen
Sevoflurane: Sevoflurane with an LMA
|
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.
Sevoflurane: Sevoflurane with an LMA
|
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.
Sevoflurane: Sevoflurane with an LMA
Isoflurane: Isoflurane with an LMA
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
5
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
5
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Anesthesia Emergence and Behavioral Changes in Children Undergoing MRI
Baseline characteristics by cohort
| Measure |
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.
Propofol: Propofol infusion with nasal oxygen
Propofol: Propofol infusion with an LMA
|
Sevoflurane, Propofol, LMA
n=5 Participants
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
|
Sevoflurane, Sevoflurane, LMA
n=1 Participants
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
|
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.
Sevoflurane: Sevoflurane with an LMA
Isoflurane: Isoflurane with an LMA
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
—
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
—
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
5 participants
n=7 Participants
|
1 participants
n=5 Participants
|
—
|
6 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: WIthin 2 hours of emergence from anesthesiaPopulation: none recruited that that group
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.
Outcome measures
| Measure |
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.
Propofol: Propofol infusion with nasal oxygen
Propofol: Propofol infusion with an LMA
|
Sevoflurane, Sevoflurane, LMA
n=1 Participants
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
|
Sevoflurane, Propofol, LMA
n=5 Participants
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
|
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.
Sevoflurane: Sevoflurane with an LMA
Isoflurane: Isoflurane with an LMA
|
|---|---|---|---|---|
|
Incidence of Delirium on Emergence
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: WIthin 2 hours of emergence from anesthesiaPopulation: none recruited to that group
All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation \<92% for \>15 s regardless of the cause, bronchospasm, secretions and hiccups
Outcome measures
| Measure |
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.
Propofol: Propofol infusion with nasal oxygen
Propofol: Propofol infusion with an LMA
|
Sevoflurane, Sevoflurane, LMA
n=1 Participants
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
|
Sevoflurane, Propofol, LMA
n=5 Participants
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
|
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.
Sevoflurane: Sevoflurane with an LMA
Isoflurane: Isoflurane with an LMA
|
|---|---|---|---|---|
|
Incidence of Airway Complications
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
Adverse Events
Sevoflurane, Propofol, Nasal Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sevoflurane, Sevoflurane, LMA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sevoflurane, Propofol, LMA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sevoflurane, Isoflurane, LMA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place