Trial Outcomes & Findings for Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery (NCT NCT02521259)

Results Overview

Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval.

Recruitment status

COMPLETED

Target enrollment

68 participants

Primary outcome timeframe

30 minutes

Results posted on

2019-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Normal Bispectral Index (BIS) Group Bispectral index (BIS) range from 40 to 60 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.	Low Bispectral Index (BIS) Group BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
Overall Study STARTED	35	33
Overall Study COMPLETED	34	28
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Bispectral Index (BIS) Group n=28 Participants BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.	Normal BIS Group n=34 Participants BIS range from 40 to 60 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	28 Participants n=28 Participants	34 Participants n=34 Participants	62 Participants n=62 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=28 Participants	0 Participants n=34 Participants	0 Participants n=62 Participants
Age, Categorical >=65 years	0 Participants n=28 Participants	0 Participants n=34 Participants	0 Participants n=62 Participants
Sex: Female, Male Female	15 Participants n=28 Participants	18 Participants n=34 Participants	33 Participants n=62 Participants
Sex: Female, Male Male	13 Participants n=28 Participants	16 Participants n=34 Participants	29 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 30 minutes

Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval.

Outcome measures

Outcome measures
Measure	Low Bispectral Index (BIS) Group n=28 Participants BIS range under 40 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.	Normal BIS Group n=34 Participants BIS range from 40 to 60 BIS: BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
the Pediatric Anesthesia Emergence Delirium (PAED) Score T1 (on arrival PACU)	12.5 score on a scale Standard Deviation 5.0	11.4 score on a scale Standard Deviation 5.4
the Pediatric Anesthesia Emergence Delirium (PAED) Score T2 (15 minutes after T1)	6.5 score on a scale Standard Deviation 1.3	5.4 score on a scale Standard Deviation 3.4
the Pediatric Anesthesia Emergence Delirium (PAED) Score T3 (15 minutes after T2)	3.2 score on a scale Standard Deviation 2.0	3.4 score on a scale Standard Deviation 2.5

Adverse Events

Low Bispectral Index (BIS) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal BIS Group

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

Dr. YEA JI LEE

Seoul National University Bundang Hospital

Phone: +821086307701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place