Trial Outcomes & Findings for Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia (NCT NCT06482125)
NCT ID: NCT06482125
Last Updated: 2025-05-28
Results Overview
Cravero scale uses a numeric scale. 1 = obtunded with no response to stimulation; 2 = asleep, but responsive to movement or stimuli; 3 = awake and responsive, 4 = crying; 5 = thrashing behavior that requires restraint. Minimum values of NOT AGITATED is 1.0 up to maximum of 2.9. Minimum values of AGITATED is 3.10 up to maximum of 5.0. Cravero scale is measured from the moment of extubation and every 15 minutes thereafter until the patient is completely awakened (in the recovery room). The total score is summed, and the average is reported.
COMPLETED
NA
121 participants
Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.
2025-05-28
Participant Flow
Inclusion criteria were: American Society of Anesthesiologists (ASA) physical status I or II patients, weighing not more than 25 kg were scheduled to undergo cleft lip or palate repair. Exclusion criteria were children with congenital heart disease; syndromic children, and/or children with a history of epilepsy and liver dysfunction.
Participant milestones
| Measure |
Inhalation Sevoflurane
Participants in this group will receive inhalation anesthesia Sevoflurane at 2-3 Vol% as their sole anesthetic maintenance agent throughout the surgical procedure.
Inhalation Sevoflurane: Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure.
|
Total Intravenous Dexmedetomidine
Participants in this group will receive Total Intravenous Dexmedetomidine as their sole anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour will be given throughout the surgical procedure.
Total Intravenous Dexmedetomidine: Intervention group will receive Total Intravenous Dexmedetomidine as their anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour continued as the sole anesthetic maintenance agent, thereafter.
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|---|---|---|
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Overall Study
STARTED
|
62
|
59
|
|
Overall Study
COMPLETED
|
62
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measures preschool children ages only 2 to 5 years old, population at high risk to experience emergence agitation
Baseline characteristics by cohort
| Measure |
Inhalation Sevoflurane
n=62 Participants
Subjects receiving Sevoflurane as their maintenance anesthetic
|
Total Intravenous Dexmedetomidine
n=59 Participants
Subjects receiving Dexmedetomidine as their maintenance anesthetic
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24 months
n=62 Participants
|
24 months
n=59 Participants
|
24 months
n=121 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=62 Participants
|
29 Participants
n=59 Participants
|
61 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=62 Participants
|
30 Participants
n=59 Participants
|
60 Participants
n=121 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=62 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=62 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
62 Participants
n=62 Participants
|
59 Participants
n=59 Participants
|
121 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=62 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=62 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=62 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=62 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=121 Participants
|
|
Weight (kg)
|
11.4 kilogram
STANDARD_DEVIATION 5.4 • n=62 Participants
|
10.6 kilogram
STANDARD_DEVIATION 5.0 • n=59 Participants
|
10.9 kilogram
STANDARD_DEVIATION 5.2 • n=121 Participants
|
|
Type of operation (Labioplasty/Palatoplasty)
Labioplasty
|
30 Participants
n=62 Participants
|
33 Participants
n=59 Participants
|
63 Participants
n=121 Participants
|
|
Type of operation (Labioplasty/Palatoplasty)
Palatoplasty
|
32 Participants
n=62 Participants
|
26 Participants
n=59 Participants
|
58 Participants
n=121 Participants
|
|
Preschool Children
|
3.4 years
STANDARD_DEVIATION 1.1 • n=21 Participants • Measures preschool children ages only 2 to 5 years old, population at high risk to experience emergence agitation
|
3.2 years
STANDARD_DEVIATION 1.1 • n=21 Participants • Measures preschool children ages only 2 to 5 years old, population at high risk to experience emergence agitation
|
3.3 years
STANDARD_DEVIATION 1.1 • n=42 Participants • Measures preschool children ages only 2 to 5 years old, population at high risk to experience emergence agitation
|
|
Modified Yale Preoperative Anxiety Scale (mYPAS)
|
56.1 units on a scale
STANDARD_DEVIATION 13.7 • n=21 Participants • Only measures Preschool children population ages 2 - 5 years old
|
54.3 units on a scale
STANDARD_DEVIATION 15.0 • n=21 Participants • Only measures Preschool children population ages 2 - 5 years old
|
55.2 units on a scale
STANDARD_DEVIATION 14.2 • n=42 Participants • Only measures Preschool children population ages 2 - 5 years old
|
PRIMARY outcome
Timeframe: Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.Population: Scale of 1.0 - 2.9 indicates no emergence agitation, a scale of 3.0 - 5.0 indicates emergence agitation
Cravero scale uses a numeric scale. 1 = obtunded with no response to stimulation; 2 = asleep, but responsive to movement or stimuli; 3 = awake and responsive, 4 = crying; 5 = thrashing behavior that requires restraint. Minimum values of NOT AGITATED is 1.0 up to maximum of 2.9. Minimum values of AGITATED is 3.10 up to maximum of 5.0. Cravero scale is measured from the moment of extubation and every 15 minutes thereafter until the patient is completely awakened (in the recovery room). The total score is summed, and the average is reported.
Outcome measures
| Measure |
Inhalation Sevoflurane
n=62 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
Total Intravenous Dexmedetomidine
n=59 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
|---|---|---|
|
Emergence Agitation
|
3.9 Score on a scale
Standard Deviation 0.9
|
2.5 Score on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.Measures the time of anesthesia (in minutes) starting from induction of anesthesia to the termination of anesthetic agent
Outcome measures
| Measure |
Inhalation Sevoflurane
n=62 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
Total Intravenous Dexmedetomidine
n=59 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
|---|---|---|
|
Duration of Anesthesia (Minutes)
|
50 minutes
Standard Deviation 17
|
46 minutes
Standard Deviation 15
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PRIMARY outcome
Timeframe: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.Measures the time of surgery after the application of sterile draping up to the end of surgery.
Outcome measures
| Measure |
Inhalation Sevoflurane
n=62 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
Total Intravenous Dexmedetomidine
n=59 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
|---|---|---|
|
Duration of Surgery (Minutes)
|
41 minutes
Standard Deviation 15
|
39 minutes
Standard Deviation 14
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SECONDARY outcome
Timeframe: Maximum time to extubate was up to 26 minutes.Measures the amount of time taken to extubate. Time is recorded from the moment Sevoflurane is stopped or Dexmedetomidine infusion is stopped until the patient is fit to extubated.
Outcome measures
| Measure |
Inhalation Sevoflurane
n=62 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
Total Intravenous Dexmedetomidine
n=59 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
|---|---|---|
|
Time to Extubation (Minutes)
|
9.5 minutes
Standard Deviation 3.7
|
10.4 minutes
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Maximum time observed was up to 105 minutes.Measures amount of time taken to full awakening. Time is recorded from the moment of extubation until patient completely awaken at the recovery room area.
Outcome measures
| Measure |
Inhalation Sevoflurane
n=62 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
Total Intravenous Dexmedetomidine
n=59 Participants
Cravero Score is measured every 15 minutes until patient has fully recovered. The average score per person is reported.
|
|---|---|---|
|
Time to Full Recovery
|
51.7 minutes
Standard Deviation 16.3
|
59.9 minutes
Standard Deviation 16.4
|
Adverse Events
Inhalation Sevoflurane
Intravenous Dexmedetomidine
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