Trial Outcomes & Findings for The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy (NCT NCT02952222)

NCT ID: NCT02952222

Last Updated: 2024-05-10

Results Overview

Compare the total propofol requirements (in mg/kg/min) of children who receive intravenous propofol with pre-treatment of dexmedetomidine with the propofol requirements in children who do not receive dexmedetomidine.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 39 participants
• Primary outcome timeframe: up to 3 hours
• Results posted on: 2024-05-10

Participant Flow

Participant milestones

Measure	Propofol (Group P) Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a Bispectral Index (BIS) of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg Dexmedetomidine (DEX) bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Overall Study STARTED	19	20
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Synergistic Effect of Dexmedetomidine on Propofol for Sedation for Pediatric Endoscopy

Baseline characteristics by cohort

Measure	Propofol (Group P) n=19 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=20 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	19 Participants n=93 Participants	20 Participants n=4 Participants	39 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	13.2 years STANDARD_DEVIATION 2.9 • n=93 Participants	14.4 years STANDARD_DEVIATION 3.2 • n=4 Participants	13.9 years STANDARD_DEVIATION 3.0 • n=27 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	10 Participants n=4 Participants	23 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants	19 Participants n=4 Participants	34 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	20 participants n=4 Participants	39 participants n=27 Participants

PRIMARY outcome

Timeframe: up to 3 hours

Compare the total propofol requirements (in mg/kg/min) of children who receive intravenous propofol with pre-treatment of dexmedetomidine with the propofol requirements in children who do not receive dexmedetomidine.

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Propofol Requirements With Pre-treatment of Dexmedetomidine With Children Who do Not Receive Dexmedetomidine.	0.4 mg/kg/min Interval 0.2 to 0.5	0.23 mg/kg/min Interval 0.1 to 0.5

SECONDARY outcome

Timeframe: 1 day

To compare propofol to dexmedetomidine with respect to the frequency of adverse events and the need for airway interventions

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Frequency of Adverse Events and the Need for Airway Interventions	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 30 minutes

To compare propofol to dexmedetomidine with respect to the time required to receive sedation

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Time Required to Achieve Sedation	7.5 minutes Interval 3.0 to 14.0	7 minutes Interval 3.0 to 12.0

SECONDARY outcome

Timeframe: up to 4 hours

To compare the propofol-only group to dexmedetomidine-propofol group with respect to the time required to meet discharge criteria from recovery room

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Time Required to Meet Discharge Criteria From Recovery Room	63 minutes Interval 46.0 to 91.0	60 minutes Interval 20.0 to 121.0

SECONDARY outcome

Timeframe: 3 days

To compare the propofol-only group to dexmedetomidine-propofol group with respect to adverse events

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Adverse Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 3 hours

To compare the propofol-only group to dexmedetomidine-propofol group with respect to the need for unplanned airway interventions

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Number of Unplanned Airway Interventions According to the World Society of Intravenous Anaesthesia (SIVA) Adverse Sedation Event Reporting Tool	0 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 4 hours

To compare the propofol-only group to dexmedetomidine-propofol group with respect to the Pediatric Anesthesia Emergence Delirium (PAED) score. The PAED is a scale that measures emergence delirium in children and adolescence as they wake up from anesthesia. The lowest achievable score is 0 and is consistent with no emergence delirium (best outcome). The highest achievable score is 20 and is consistent with emergence delirium (worse outcome).

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Emergence Delirium Score>=10	15 Participants	18 Participants
Emergence Delirium Score<10	1 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 6 hours

To compare the propofol-only group to dexmedetomidine-propofol group with respect to time (in minutes) of return of BIS score to baseline (pre-sedation level) in recovery room

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Time to BIS Score	45 minutes Interval 35.0 to 53.0	50 minutes Interval 26.0 to 54.0

SECONDARY outcome

Timeframe: up to 3 hours

To compare the propofol-only group to dexmedetomidine-propofol group with respect to the duration of sedation

Outcome measures

Measure	Propofol (Group P) n=16 Participants Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 Participants Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Duration of Sedation	22 minutes Interval 10.0 to 72.0	33 minutes Interval 10.0 to 93.0

Adverse Events

Propofol (Group P)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol With Dexmedetomidine (Group DP)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Propofol (Group P) n=16 participants at risk Propofol only Propofol (Group P): Patients in Group P will receive intravenous propofol in bolus increments (2.0 mg/kg bolus over one minute then 0.5 mg/kg bolus q 1 minute titrated to a BIS of 40-50). These patients will be maintained with a continuous intravenous infusion of propofol starting at 200 mcg/kg/min and will be titrated to an endpoint of maintaining a BIS level of 40-50.	Propofol With Dexmedetomidine (Group DP) n=19 participants at risk Propofol with Dexmedetomidine Dexmedetomidine: Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure. Propofol (Group DP): Patients in Group DP will receive 0.5 mcg/kg DEX administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Following the 0.5 mcg/kg DEX bolus, propofol will be administered with the identical protocol (with same endpoint of BIS 40-50) of the P Group. Propofol infusion will be started at 200 mcg/kg/min and will be titrated throughout the procedure to maintain a BIS 40-50. Propofol may be administered prn in 10-20 mg increments for any abrupt patient movement which may compromise the continuity of the procedure.
Respiratory, thoracic and mediastinal disorders Question of Bronchospasm and laryngospam	0.00% 0/16 • Adverse event data were collected for each patient for up to 3 days, starting from the time of first drug administration (DEX or propofol).	5.3% 1/19 • Number of events 1 • Adverse event data were collected for each patient for up to 3 days, starting from the time of first drug administration (DEX or propofol).

Additional Information

Dr. Keira Mason

Boston Children's Hospital

Phone: (617) 355-7737

Email: keira.mason@childrens.harvard.edu

Results disclosure agreements

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