Trial Outcomes & Findings for Dexmedetomidine and Propofol for Pediatric MRI Sedation (NCT NCT03513757)

NCT ID: NCT03513757

Last Updated: 2020-02-21

Results Overview

Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: through study completion, an average of 2 hours
• Results posted on: 2020-02-21

Participant Flow

Participant milestones

Measure	Propofol Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg
Overall Study STARTED	22	18
Overall Study COMPLETED	22	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mic/kg/min. Dose will be increased by 50 mic/kg/min up to 300 mic/kg/min for movement and decreased to 150 mic/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mic/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mic/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mic/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg	Total n=40 Participants Total of all reporting groups
Age, Continuous	39 months n=22 Participants	26 months n=18 Participants	34 months n=40 Participants
Sex: Female, Male Female	9 Participants n=22 Participants	7 Participants n=18 Participants	16 Participants n=40 Participants
Sex: Female, Male Male	13 Participants n=22 Participants	11 Participants n=18 Participants	24 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	22 Participants n=22 Participants	18 Participants n=18 Participants	40 Participants n=40 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 2 hours

Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion	98 minutes Interval 86.0 to 115.0	77 minutes Interval 64.0 to 102.0

SECONDARY outcome

Timeframe: up to 90 minutes

total propofol administered (mg/kg)

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Total Propofol Administered	10.6 mg/kg Interval 9.2 to 12.9	3.0 mg/kg Interval 2.0 to 3.7

SECONDARY outcome

Timeframe: up to 90 minutes

dexmedetomidine dose (mcg/kg)

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Dexmedetomidine Dose	0 mcg/kg Interval 0.0 to 0.0	0.70 mcg/kg Interval 0.7 to 1.0

SECONDARY outcome

Timeframe: 5 minutes

glycopyrrolate dose (mcg/kg)

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Glycopyrrolate Dose	0 mcg/kg Interval 0.0 to 0.0	4.2 mcg/kg Interval 4.0 to 4.8

SECONDARY outcome

Timeframe: up to 90 minutes

lidocaine dose (mg/kg)

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Lidocaine Dose	1.00 mg/kg Interval 0.97 to 1.03	1.00 mg/kg Interval 0.96 to 1.05

SECONDARY outcome

Timeframe: up to 10 minutes

documentation of use

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Nitrous Oxide	18 participants	17 participants

SECONDARY outcome

Timeframe: sevoflurane induction time up to 10 minutes

sevoflurane induction time of 5 minutes

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Sevoflurane	18 participants	17 participants

SECONDARY outcome

Timeframe: up to 90 minutes

minutes from completion of scan to spontaneous eye opening

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Eye Opening	28 minutes Interval 23.0 to 34.0	3 minutes Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: up to 2 hours

minutes from completion of scan to oral/enteral intake

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Oral/Enteral Intake	33 minutes Interval 29.0 to 42.0	14 minutes Interval 7.0 to 17.0

SECONDARY outcome

Timeframe: up to 2 hours

minutes from completion of scan to discharge ready

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Discharge Ready	40 minutes Interval 33.0 to 53.0	17 minutes Interval 9.0 to 31.0

SECONDARY outcome

Timeframe: up to 48 hours

parental observation of deviation from child's normal habit obtained through follow-up phone call

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Sleep Pattern	3 participants	2 participants

SECONDARY outcome

Timeframe: up to 48 hours

behavior deemed inappropriate and a deviation from child's normal though parental observation obtained through follow-up phone call

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Irritability	3 participants	0 participants

SECONDARY outcome

Timeframe: up to 24 hours.

Pediatric Anesthesia Emergence Delirium (PAED) score greater than 12 as defined by Sikich and Lerman. 0 = no delirium, 20 = worst possible delirium; 5 categories scored from 0-4 additive for a maximum score of 20. Categories 1-3 are scored the same and categories ar scored inversely as described. 1. Child makes contact with caregiver, 2. child's actions are purposeful, 3. child is aware of his surroundings. For each of these category, score 0 for extremely, 1 for very much, 2 for quite a bit, 3 for just a little, 4 for not at all. The other 2 categories 4. Child is restless and 5 Child is inconsolable are scored as 0 for not at all, 1 for just a little, 2 for quite a bit, 3 for very much, 4 for extremely

Outcome measures

Measure	Propofol n=22 Participants Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 Participants Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.
Delirium	0 participants	0 participants

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Propofol Dexmedetomidine

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Propofol n=22 participants at risk Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists	Propofol Dexmedetomidine n=18 participants at risk Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg
Injury, poisoning and procedural complications respiratory events during induction/anesthesia/recovery	45.5% 10/22 • Number of events 10 • 48 hours	44.4% 8/18 • Number of events 8 • 48 hours
Injury, poisoning and procedural complications movement	13.6% 3/22 • Number of events 3 • 48 hours	11.1% 2/18 • Number of events 4 • 48 hours

Additional Information

Susan Taylor MD

Medical College of Wisconsin

Phone: 414-266-3560

Email: sutaylor@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place