Trial Outcomes & Findings for Propofol in Obese Children (NCT NCT01242241)

Last Updated: 2020-12-21

Results Overview

Propofol is administered over 10 seconds. 20 seconds after adminstration, loss of consciousness is assessed by the presence or absence of a lash reflex. The dose responsible for loss of lash reflex/consciousness in 95% of patients was determined in mg/kg.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

80 participants

Primary outcome timeframe

20 seconds

Results posted on

2020-12-21

Participant Flow

Patients were recruited in the operating room setting between the period of April 2008 to December 2011

A total of 213 patients were screened for study eligibility. Eighty-two patients were excluded; 51 did not meet inclusion criteria either becasue they declined participation, did not have intravenous access, were re-scheduled due to inadequate preparation for surgery or patient illness. All patients enrolled completed the study.

Participant milestones

Participant milestones
Measure	Obese Children Obese children are categorized as those with a body mass index \>95th percentile Propofol : Each Obese child/subject in this group received a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)	Non-obese Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile Propofol : This arm of patients(non-obese)served as the control group for the obese children. Each non-obese child/subject received a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Propofol in Obese Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese Children n=40 Participants Obese children are categorized as those with a body mass index \>95th percentile Propofol : Each Obese child/subject in this group received a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)	Non-obese n=40 Participants Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile Propofol : This arm of patients(non-obese)served as the control group for the obese children. Each non-obese child/subject received a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	40 Participants n=5 Participants	40 Participants n=7 Participants	80 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	12.69 years STANDARD_DEVIATION 2.89 • n=5 Participants	12.70 years STANDARD_DEVIATION 3.90 • n=7 Participants	12.69 years STANDARD_DEVIATION 3.43 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Body Mass Index	30.29 kg/m^2 STANDARD_DEVIATION 5.12 • n=5 Participants	19.01 kg/m^2 STANDARD_DEVIATION 2.60 • n=7 Participants	24.65 kg/m^2 STANDARD_DEVIATION 6.95 • n=5 Participants

PRIMARY outcome

Timeframe: 20 seconds

Population: The sample size of 40 patients in each group was based on previous simulation studies which used the biased coin design in which a group size of 20-40 patients was shown to demonstrate stable estimates of the target dose for most scenarios.

Outcome measures

Outcome measures
Measure	Obese Children n=40 Participants Obese children are categorized as those with a body mass index \>95th percentile Propofol : Each Obese child/subject in this group received a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)	Non-obese n=40 Participants Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile Propofol : This arm of patients(non-obese)served as the control group for the obese children. Each non-obese child/subject received a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Dose of Propofol That Caused Loss of Consciousness in 95% (ED95) of Obese and Non-obese Children	2 mg/kg Interval 1.0 to 2.25	2.125 mg/kg Interval 1.0 to 3.25

SECONDARY outcome

Timeframe: 30 seconds, 1 minute, and 2 minutes

Population: Due to unavoidable circumstances during a clinical surgery, depth of sedation was not able to be collected on every subject at every time point.

After propofol administration, the patient was assessed for depth of sedation at 30 seconds, 1 minute, and 2 minutes using the University of Michigan Sedation Scale (UMSS) and Ramsay Sedation Scale. UMSS assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). Ramsay Sedation Scale assesses the level of sedation on a six-point scale ranging from 1 (Patient is anxious and agitated or restless, or both) to 6 (Patient exhibits no response).

Outcome measures

Outcome measures
Measure	Obese Children n=40 Participants Obese children are categorized as those with a body mass index \>95th percentile Propofol : Each Obese child/subject in this group received a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)	Non-obese n=40 Participants Non-obese children categorized as those with a body mass index(BMI)between 25-84th percentile Propofol : This arm of patients(non-obese)served as the control group for the obese children. Each non-obese child/subject received a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
Depth of Sedation UMSS - 1 minute	3.86 units on a scale Interval 1.0 to 4.0	3.73 units on a scale Interval 1.0 to 4.0
Depth of Sedation Ramsay - 1 minute	5.92 units on a scale Interval 4.0 to 6.0	5.83 units on a scale Interval 2.0 to 6.0
Depth of Sedation UMSS - 30 seconds	3.65 units on a scale Interval 1.0 to 4.0	3.57 units on a scale Interval 1.0 to 4.0
Depth of Sedation UMSS - 2 minutes	3.82 units on a scale Interval 1.0 to 4.0	3.67 units on a scale Interval 1.0 to 4.0
Depth of Sedation Ramsay - 30 seconds	5.74 units on a scale Interval 2.0 to 6.0	5.71 units on a scale Interval 1.0 to 6.0
Depth of Sedation Ramsay - 2 minutes	5.92 units on a scale Interval 4.0 to 6.0	5.86 units on a scale Interval 2.0 to 6.0

Adverse Events

Non-obese

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obese Children

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. Olutoyin A. Olutoye

Baylor College of Medicine

Phone: 832-824-5800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place