Trial Outcomes & Findings for The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children (NCT NCT00990769)

Results Overview

The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Within 30 minutes of arrival in recovery room

Results posted on

2013-05-31

Participant Flow

Parents or guardians of children undergoing ophthalmologic surgery were approached, when possible, at their pre-anesthesia evaluation visit. All eligible patients were notified about the study through fliers at their pre-operative visit, and eligible patients who were missed pre-operatively were approached for consent on the day of surgery.

Fifty-seven patients were approached for participation; of these, fourteen declined and three were unable to participate due to surgery cancellation or rescheduling.

Participant milestones

Participant milestones
Measure	High-normal BIS Depth of anesthesia is titrated to a BIS level of 55-60	Low-normal BIS Depth of anesthesia is titrated to a BIS level of 40-45
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

The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-normal BIS n=22 Participants Depth of anesthesia is titrated to a BIS level of 55-60	Low-normal BIS n=18 Participants Depth of anesthesia is titrated to a BIS level of 40-45	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	5.1 years STANDARD_DEVIATION 2.3 • n=5 Participants	4.3 years STANDARD_DEVIATION 1.4 • n=7 Participants	4.7 years STANDARD_DEVIATION 1.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	18 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 minutes of arrival in recovery room

Population: All patients in each group were analyzed.

The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.

Outcome measures

Outcome measures
Measure	High-normal BIS n=22 Participants Depth of anesthesia is titrated to a BIS level of 55-60	Low-normal BIS n=18 Participants Depth of anesthesia is titrated to a BIS level of 40-45
Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)	8.6 units on a scale Standard Deviation 5.3	6.7 units on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: After the completion of surgery

Population: All patients were analyzed

The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.

Outcome measures

Outcome measures
Measure	High-normal BIS n=22 Participants Depth of anesthesia is titrated to a BIS level of 55-60	Low-normal BIS n=18 Participants Depth of anesthesia is titrated to a BIS level of 40-45
Time to Emergence From Anesthesia	14 minutes Standard Deviation 5	12 minutes Standard Deviation 4

SECONDARY outcome

Timeframe: Within 30 minutes of arrival in recovery room

Population: All patients were analyzed.

Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.

Outcome measures

Outcome measures
Measure	High-normal BIS n=22 Participants Depth of anesthesia is titrated to a BIS level of 55-60	Low-normal BIS n=18 Participants Depth of anesthesia is titrated to a BIS level of 40-45
Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)	5.3 units on a scale Standard Deviation 3.3	3.5 units on a scale Standard Deviation 3.8

Adverse Events

High-normal BIS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low-normal BIS

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. Heather Frederick

Duke University Medical Center

Phone: 919-812-6204

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place