Trial Outcomes & Findings for Use of a Modified Propofol Emulsion in Adults (NCT NCT00690495)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

during first propofol bolus

Results posted on

2012-01-05

Participant Flow

First patient in: 07.05.2008 Last patient out: 24.09.2008

Participant milestones

Participant milestones
Measure	Modified Propofol Modified propofol (Propofol 0.5%)	Propofol 1% Propofol 1%
Overall Study STARTED	50	50
Overall Study Primary Endpoint	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of a Modified Propofol Emulsion in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified Propofol n=50 Participants Modified propofol (Propofol 0.5%)	Propofol 1% n=50 Participants Propofol 1%	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=99 Participants	34 Participants n=107 Participants	68 Participants n=206 Participants
Age, Categorical >=65 years	16 Participants n=99 Participants	16 Participants n=107 Participants	32 Participants n=206 Participants
Age Continuous	54.4 years STANDARD_DEVIATION 14.6 • n=99 Participants	55.2 years STANDARD_DEVIATION 13.9 • n=107 Participants	54.8 years STANDARD_DEVIATION 14.2 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	15 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	39 Participants n=99 Participants	35 Participants n=107 Participants	74 Participants n=206 Participants
Region of Enrollment Germany	50 participants n=99 Participants	50 participants n=107 Participants	100 participants n=206 Participants

PRIMARY outcome

Timeframe: during first propofol bolus

Population: per protocol

Outcome measures

Outcome measures
Measure	Modified Propofol n=50 Participants Modified propofol (Propofol 0.5%)	Propofol 1% n=50 Participants Propofol 1%
Incidence of Expression of Pain During Injection	1 participants	7 participants

SECONDARY outcome

Timeframe: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia

Outcome measures

Outcome data not reported

Adverse Events

Modified Propofol

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Propofol 1%

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Modified Propofol n=50 participants at risk Modified propofol (Propofol 0.5%)	Propofol 1% n=50 participants at risk Propofol 1%
Metabolism and nutrition disorders hypertriglyceridaemia	88.0% 44/50 • Number of events 44	52.0% 26/50 • Number of events 26

Additional Information

Study manager

B.Braun Melsungen AG

Phone: +49 5661 71

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60