Trial Outcomes & Findings for Effect General and Regional Anesthesia on Glycocalyx (NCT NCT02783443)
NCT ID: NCT02783443
Last Updated: 2019-11-27
Results Overview
PBR is an indirect measure of glycocalyx thickness
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
Change from baseline PBR at 24 hours after surgery
Results posted on
2019-11-27
Participant Flow
Participant milestones
| Measure |
General Anesthesia
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
General anesthesia: General anesthesia
|
Regional Anesthesia
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia: Regional anesthesia
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect General and Regional Anesthesia on Glycocalyx
Baseline characteristics by cohort
| Measure |
General Anesthesia
n=30 Participants
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
General anesthesia: General anesthesia
|
Regional Anesthesia
n=30 Participants
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia: Regional anesthesia
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 7 • n=93 Participants
|
67 years
STANDARD_DEVIATION 9 • n=4 Participants
|
66 years
STANDARD_DEVIATION 8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Czechia
|
30 participants
n=93 Participants
|
30 participants
n=4 Participants
|
60 participants
n=27 Participants
|
|
Baseline PBR
|
2.02 micrometer
STANDARD_DEVIATION 0.26 • n=93 Participants
|
1.95 micrometer
STANDARD_DEVIATION 0.24 • n=4 Participants
|
1.99 micrometer
STANDARD_DEVIATION 0.25 • n=27 Participants
|
PRIMARY outcome
Timeframe: Change from baseline PBR at 24 hours after surgeryPBR is an indirect measure of glycocalyx thickness
Outcome measures
| Measure |
General Anesthesia
n=30 Participants
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
General anesthesia: General anesthesia
|
Regional Anesthesia
n=30 Participants
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia: Regional anesthesia
|
|---|---|---|
|
Change in Perfused Boundary Region (PBR)
|
2.20 micrometer
Standard Deviation 0.25
|
2.09 micrometer
Standard Deviation 0.19
|
Adverse Events
General Anesthesia
Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths
Regional Anesthesia
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
General Anesthesia
n=30 participants at risk
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
General anesthesia: General anesthesia
|
Regional Anesthesia
n=30 participants at risk
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia: Regional anesthesia
|
|---|---|---|
|
Gastrointestinal disorders
PONV
|
26.7%
8/30 • Number of events 8 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
0.00%
0/30 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
|
Blood and lymphatic system disorders
anemia
|
6.7%
2/30 • Number of events 2 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
0.00%
0/30 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
|
Gastrointestinal disorders
obstipation
|
0.00%
0/30 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
3.3%
1/30 • Number of events 1 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
|
Nervous system disorders
delirium
|
6.7%
2/30 • Number of events 2 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
0.00%
0/30 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
Other adverse events
| Measure |
General Anesthesia
n=30 participants at risk
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general anaesthesia.
General anesthesia: General anesthesia
|
Regional Anesthesia
n=30 participants at risk
Adult patients ASA 2-3 undergoing elective total knee replacement surgery under regional anaesthesia.
Regional anesthesia: Regional anesthesia
|
|---|---|---|
|
Nervous system disorders
pain
|
40.0%
12/30 • Number of events 12 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
3.3%
1/30 • Number of events 1 • 1 year
A serious adverse event represents a situation that required patient transport to the ICU or prolongation of stay in the hospital. The other adverse event represents a situation in which a doctor had been called but with no impact on patient stay or short-term outcome.
|
Additional Information
Dr. David Astapenko
University Hospital Hradec Kralove
Phone: +420608177374
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place