Trial Outcomes & Findings for Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children (NCT NCT00857727)

NCT ID: NCT00857727

Last Updated: 2018-11-27

Results Overview

Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 33 participants
• Primary outcome timeframe: 15-45 minutes post-op
• Results posted on: 2018-11-27

Participant Flow

33 children undergoing general anesthesia for endovascular interventional procedures. 28 patients provided complete data sets.

Participant milestones

Measure	Drug Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control Normal Saline IV solution - Given by a continuous infusion
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children

Baseline characteristics by cohort

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion	Total n=28 Participants Total of all reporting groups
Age, Continuous	5.2 years STANDARD_DEVIATION 2.6 • n=93 Participants	4.2 years STANDARD_DEVIATION 2.7 • n=4 Participants	4.7 years STANDARD_DEVIATION 2.8 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants

PRIMARY outcome

Timeframe: 15-45 minutes post-op

Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Number of Participants With Emergence Delirium ED	1 participants	7 participants
Number of Participants With Emergence Delirium No ED	13 participants	7 participants

SECONDARY outcome

Timeframe: 24 hours

Population: data were not collected

Vital signs were not collected as part of research study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Weight	21.8 kg Standard Deviation 7.3	18.5 kg Standard Deviation 8.1

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Length of Anesthesia	199 minutes Standard Deviation 71	215 minutes Standard Deviation 156

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Length of Surgery	58 minutes Standard Deviation 43	86 minutes Standard Deviation 149

SECONDARY outcome

Timeframe: Day 1

Total Study Drug used

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Total Study Drug	1.55 mcg/kg Standard Deviation 0.32	1.43 mcg/kg Standard Deviation 0.32

SECONDARY outcome

Timeframe: Day 1

Total Drug used

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Total Sevoflurane	3.67 ml/kg Standard Deviation 1.38	6.80 ml/kg Standard Deviation 7.81

SECONDARY outcome

Timeframe: Day 1

Total Drug used

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Total Propofol	2.11 mg/kg Standard Deviation 1.28	2.41 mg/kg Standard Deviation 1.36

SECONDARY outcome

Timeframe: Day 1

Total Drug used

Outcome measures

Measure	Drug n=14 Participants Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 Participants Normal Saline IV solution - Given by a continuous infusion
Total Fentanyl	2.33 mcg/kg Standard Deviation 0.79	2.36 mcg/kg Standard Deviation 0.99

Adverse Events

Drug

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Drug n=14 participants at risk Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Control n=14 participants at risk Normal Saline IV solution - Given by a continuous infusion
Cardiac disorders Severe bradycardia	0.00% 0/14 Two adverse events were noted requiring unblinding	7.1% 1/14 • Number of events 1 Two adverse events were noted requiring unblinding
General disorders Excessive sedation	7.1% 1/14 • Number of events 1 Two adverse events were noted requiring unblinding	0.00% 0/14 Two adverse events were noted requiring unblinding

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jinu Kim

Mount Sinai St. Luke's

Phone: 212-523-6121

Email: JiKim@chpnet.org

Results disclosure agreements

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