Trial Outcomes & Findings for Propofol in Emergence Agitation (NCT NCT00535613)

Results Overview

Incidence of Emergent Agitation is defined as a Paediatric Anaesthesia Emergence Delirium (PAED) score above 10 at any point at the defined protocol time points (recovery, 5, 10, 15, 20, 25, or 30 minutes)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

99 participants

Primary outcome timeframe

up to 30 min post surgery

Results posted on

2019-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Propofol Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	Placebo No propofol
Overall Study STARTED	49	50
Overall Study COMPLETED	49	50
Overall Study NOT COMPLETED	0	0

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	Propofol n=49 Participants Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	Placebo n=50 Participants No propofol	Total n=99 Participants Total of all reporting groups
Age, Continuous	1.88 years n=49 Participants	1.72 years n=50 Participants	1.80 years n=99 Participants
Sex: Female, Male Female	2 Participants n=49 Participants	2 Participants n=50 Participants	4 Participants n=99 Participants
Sex: Female, Male Male	47 Participants n=49 Participants	48 Participants n=50 Participants	95 Participants n=99 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	49 participants n=49 Participants	50 participants n=50 Participants	99 participants n=99 Participants

PRIMARY outcome

Timeframe: up to 30 min post surgery

Incidence of Emergent Agitation is defined as a Paediatric Anaesthesia Emergence Delirium (PAED) score above 10 at any point at the defined protocol time points (recovery, 5, 10, 15, 20, 25, or 30 minutes)

Outcome measures

Outcome measures
Measure	Propofol n=49 Participants Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	Placebo n=50 Participants No propofol
Number of Participants With Emergent Agitation	16 Participants	24 Participants

SECONDARY outcome

Timeframe: up to 1 hour post surgery

Population: The study team planned to collect post anesthesia care unit discharge time from the subject medical records, however PACU discharge time was often not recorded in routine cases during the study period. This was not anticipated by the study team and retrospective analysis was not possible for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 hour post surgery

Outcome measures

Outcome measures
Measure	Propofol n=49 Participants Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg	Placebo n=50 Participants No propofol
Number of Participants Who Received Medication in the Recovery Room	3 Participants	6 Participants

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Cari Meyer

University of Wisconsin

Phone: (608) 265-5980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place