Trial Outcomes & Findings for Propofol Pharmacokinetics and Pharmacodynamics Modelling (NCT NCT02713698)
NCT ID: NCT02713698
Last Updated: 2018-09-26
Results Overview
Arterial blood samples were obtained after LOC and every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples were obtained immediately after recovery of consciousness. At the end of the surgery arterial blood samples were centrifuged at 2862xg for 5 minutes and they were preserved at -80ºC until analysis. The quantification of propofol in serum was performed using gas chromatography/ion trap-mass spectrometry (GC/IT-MS)
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
up to 2 hours
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
Group 1 (≥18 Years, BMI<35kg/m2)
Patients with 18 or more years presenting for inpatient nose and ear surgery.
|
Group 2 (≥18 Years, BMI≥35kg/m2)
Patients with 18 or more years presenting for inpatient bariatric surgery.
|
Group 3 (≥65 Years)
Patients with 65 or more years presenting for urgent orthopaedic surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propofol Pharmacokinetics and Pharmacodynamics Modelling
Baseline characteristics by cohort
| Measure |
Group 1 (≥18 Years, BMI<35kg/m2)
n=20 Participants
Patients with 18 or more years presenting for inpatient nose and ear surgery.
|
Group 2 (≥18 Years, BMI≥35kg/m2)
n=20 Participants
Patients with 18 or more years presenting for inpatient bariatric surgery.
|
Group 3 (≥65 Years)
n=20 Participants
Patients with 65 or more years presenting for urgent orthopaedic surgery.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 18.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 2 hoursArterial blood samples were obtained after LOC and every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples were obtained immediately after recovery of consciousness. At the end of the surgery arterial blood samples were centrifuged at 2862xg for 5 minutes and they were preserved at -80ºC until analysis. The quantification of propofol in serum was performed using gas chromatography/ion trap-mass spectrometry (GC/IT-MS)
Outcome measures
| Measure |
Group 1 (≥18 Years, BMI<35kg/m2)
n=20 Participants
Patients with 18 or more years presenting for inpatient nose and ear surgery.
|
Group 2 (≥18 Years, BMI≥35kg/m2)
n=20 Participants
Patients with 18 or more years presenting for inpatient bariatric surgery.
|
Group 3 (≥65 Years)
n=20 Participants
Patients with 65 or more years presenting for urgent orthopaedic surgery.
|
|---|---|---|---|
|
Plasma Propofol Concentration (mcg/mL)
|
2.36 mcg/mL
Standard Deviation 1.38
|
3.12 mcg/mL
Standard Deviation 1.5
|
2.91 mcg/mL
Standard Deviation 2.45
|
Adverse Events
Group 1 (≥18 Years, BMI<35kg/m2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (≥18 Years, BMI≥35kg/m2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 3 (≥65 Years)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (≥18 Years, BMI<35kg/m2)
n=20 participants at risk
Patients with 18 or more years presenting for inpatient nose and ear surgery.
|
Group 2 (≥18 Years, BMI≥35kg/m2)
n=20 participants at risk
Patients with 18 or more years presenting for inpatient bariatric surgery.
|
Group 3 (≥65 Years)
n=20 participants at risk
Patients with 65 or more years presenting for urgent orthopaedic surgery.
|
|---|---|---|---|
|
Cardiac disorders
Mean arterial pressure (MAP) variation >40% after induction of general anesthesia
|
0.00%
0/20 • Perioperative period
The proposed study is a cross sectional analytical study.The whole anaesthetic procedure was standard except for additional body composition assessment with Body Composition Monitor - BCM (Fresenius Medical Care, Germany) and arterial blood samples collection.
|
5.0%
1/20 • Perioperative period
The proposed study is a cross sectional analytical study.The whole anaesthetic procedure was standard except for additional body composition assessment with Body Composition Monitor - BCM (Fresenius Medical Care, Germany) and arterial blood samples collection.
|
30.0%
6/20 • Perioperative period
The proposed study is a cross sectional analytical study.The whole anaesthetic procedure was standard except for additional body composition assessment with Body Composition Monitor - BCM (Fresenius Medical Care, Germany) and arterial blood samples collection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place