Trial Outcomes & Findings for Cerebral Blood Flow During Propofol Anaesthesia (NCT NCT02951273)
NCT ID: NCT02951273
Last Updated: 2018-01-17
Results Overview
Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound.
COMPLETED
30 participants
Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.
2018-01-17
Participant Flow
Participant milestones
| Measure |
Study of Cerebral Blood Flow
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cerebral Blood Flow During Propofol Anaesthesia
Baseline characteristics by cohort
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 11 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Denmark
|
27 Participants
n=93 Participants
|
|
Internal carotid artery blood flow during anesthesia-induced hypotension
|
193 ml/min
STANDARD_DEVIATION 41 • n=93 Participants
|
PRIMARY outcome
Timeframe: Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=24 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Internal Carotid Artery Blood Flow by Treatment of Anaesthesia-induced Hypotension
|
27 ml/min
Interval 3.0 to 51.0
|
SECONDARY outcome
Timeframe: Two measurements; one measurement 5-10 min before induction of anaesthesia and one measurement 5-20 min after induction of anaesthesia.Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=30 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Internal Carotid Artery Blood Flow by Induction of Anaesthesia.
|
-144 ml/min
Interval -168.0 to -121.0
|
SECONDARY outcome
Timeframe: Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.Association by multiple regression between changes in unilateral internal carotid artery blood flow \[ml/min\] as outcome variable and changes in mean arterial pressure \[mmHg\] and cardiac output \[l/min\] as covariates. Internal carotid artery blood flow \[ml/min\] was assessed by duplex ultrasound. Mean arterial pressure \[mmHg\] was recorded by a transducer connected to an arterial line. Cardiac output \[l/min\] was evaluated by pulse contour analysis (Modelflow) that estimates cardiac output by analysis of the arterial pressure curve taking age, gender, height and weigth into account.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=24 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Association by Multiple Regression Between Changes in Internal Carotid Artery Blood Flow, Mean Arterial Pressure and Cardiac Output by Treatment of Anaesthesia-induced Hypotension.
|
376 ml/min
Standard Deviation 724
|
SECONDARY outcome
Timeframe: Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.Near-infrared spectroscopy determined frontal lobe oxygenation \[%\] as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Frontal Lobe Oxygenation by Development of Mesenteric Traction Syndrome (MTS).
|
2 oxygenation [%]
Interval -2.0 to 7.0
|
SECONDARY outcome
Timeframe: Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.Forehead skin blood flow \[PU\] assessed by laser Doppler flowmetry as compared between those patients who develop mesenteric traction syndrome (defined as flushing within 60 min after the start of surgery) and those who do not. Laser Doppler flowmetry applies a laser placed on the forehead that penetrates the skin and is scattered with a Doppler shift by the red blood cells and return to a detector that evaluates the amount of backscattered light and Doppler shift. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Forehead Skin Blood Flow by Development of Mesenteric Traction Syndrome (MTS).
|
126 PU
Interval 57.0 to 195.0
|
SECONDARY outcome
Timeframe: Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.Forehead skin oxygenation \[%\] assessed by laser Doppler flowmetry as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Forehead Skin Oxygenation by Development of Mesenteric Traction Syndrome (MTS).
|
-2 oxygenation [%]
Interval -9.0 to 5.0
|
SECONDARY outcome
Timeframe: Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Internal Carotid Artery Blood Flow by Development of Mesenteric Traction Syndrome (MTS).
|
-3 ml/min
Interval -40.0 to 35.0
|
SECONDARY outcome
Timeframe: Four measurements; before induction of anaesthesia during normoventilation and during hyperventilation to reduce PaCO2 by 1.5 kPa and during anaesthesia at a PaCO2 at the value before induction of anaesthesia and 1.5 kPa below that value.Population: Comparison of reactivity to hypocapnia when awake and during anaesthesia was evaluated by a linear mixed model with the relative change in ICA flow as outcome and fixed effects were the change in PaCO2 and an interaction factor for the difference between awake and anaesthesia. The reported result is the interaction factor.
Unilateral internal carotid artery blood flow \[ml/min\] assessed by duplex ultrasound and arterial CO2 tension (PaCO2) \[kPa\] was evaluated by gas analysis. Changes in PaCO2 are guided by evaluation of end-tidal CO2 tension. The CO2 reactivity to hypocapnia when awake and during anaesthesia is calculated as the percentage change in internal carotid artery blood flow per kPa change in PaCO2. The CO2 reactivity when awake and when anaesthetized is compared.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in the CO2 Reactivity of the Internal Carotid Artery From Before to After Induction of Anaesthesia.
|
7.4 %/kPa
Interval 2.1 to 12.7
|
SECONDARY outcome
Timeframe: Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.Heart rate \[bpm\] as recorded continuously by a transducer connected to an arterial line.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Heart Rate From Baseline Before Induction of Anaesthesia.
|
-13 beats/min
Interval -17.0 to -9.0
|
SECONDARY outcome
Timeframe: Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.Mean arterial pressure \[mmHg\] as recorded continuously by a transducer connected to an arterial line.
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Mean Arterial Pressure From Baseline Before Induction of Anaesthesia.
|
-41 mmHg
Interval -47.0 to 35.0
|
SECONDARY outcome
Timeframe: Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.Cardiac output \[l/min\] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Cardiac Output From Baseline Before Induction of Anaesthesia.
|
-2.7 l/min
Interval -3.4 to -2.0
|
SECONDARY outcome
Timeframe: Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.Stroke volume \[ml\] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).
Outcome measures
| Measure |
Study of Cerebral Blood Flow
n=27 Participants
Patients undergoing oesophageal- or ventricular resection (n=30)
Study of cerebral blood flow: Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml.
|
|---|---|
|
Changes in Stroke Volume From Baseline Before Induction of Anaesthesia.
|
-24 ml
Interval -34.0 to -14.0
|
Adverse Events
Study of Cerebral Blood Flow
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place