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Does Fluid Requirement Decrease With the Use of Pneumatic Compression Device on Lower Limbs

Impact of Intra-operative Use of Peristaltic Pneumatic Compression Device on Haemodynamics Vis-à-vis Fluid Requirement During General Anaesthesia and Surgery:A Randomized Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03789474
Enrollment
60
Registered
2018-12-28
Start date
2017-01-01
Completion date
2018-07-30
Last updated
2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Overload

Brief summary

Impact of intraoperative use of pneumatic peristaltic compression device on hemodynamics vis a vis on fluid requirement during general anaesthesia and surgery.

Detailed description

Induction of general anaesthesia is associated with cardiac depression and peripheral vasodilatation resulting in hypotension .This hypotension can be corrected by giving intravenous fluid, or the vasoconstrictor. While optimum fluid balances in the perioperative period is of vital importance in overnight fasting patients to correct the fluid deficit, any fluid overload is not only counterproductive to the heart function but is associated with fluid retention in body and edema in postoperative period. Peristaltic pneumatic compression device, a variant of intermittent sequential compression of legs, uses higher pressure and longer compression cycles to avoid venous stasis in immobilized patients. Sequential compression devices have sleeves with pockets of inflation, which works to squeeze on the appendage in a milking action .The most distal areas will inflate initially, and the subsequent pockets will follow in the same manner. The primary aim of the device is to squeeze blood from the underlying deep veins to proximal side. When the inflatable sleeves deflate, the veins will replenish with blood. The intermittent compressions of the sleeves will ensure the movement of venous blood . Peristaltic Pneumatic Compression of the legs significantly reduces fluid demand and enhances stability during minor ear, nose, and throat surgery. Peristaltic Pneumatic Compression has the potential to support fluid restriction regimens during surgery .

Interventions

DEVICEHUNTLEIGH FLOWTRON ACS900

Sponsors

All India Institute of Medical Sciences, Rishikesh
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Draping of the legs was done in both the groups.the care observer nor investigator were blinded for the allocation.

Intervention model description

About 60 patients of age group 25 to 50 belonging to American Society of Anesthesiologists (ASA) grade 1 and 2 were allocated to either control or sequential pneumatic compression device group .Allocation was done by sealed envelop technique.In the operating room,in the control group,the device was placed on operating table and was placed next to the patients calves.in the intervention group,the device was placed over calves and inflated during induction of General Anaesthesia (GA) and maintenance.legs were draped in both the groups.Femoral vein velocities were assessed using ultrasound in preoperative period , intraoperatively 15 minutes after induction of anaesthesia and in post-operative period.

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* ASA(American Society of Anaesthesiologists) grade I or II, of both genders * Age group of 25 to 50 years * Patients undergoing surgeries under GA(General Anaesthesia) for 2-3 hours

Exclusion criteria

* Patients expected to get major blood loss * Burns patients. * Patients with significant cardiac diseases. * Patients with pulmonary diseases and impaired renal function. * Lower limb surgeries and abdominal surgeries

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate at T015 minutes pre inductionheart rate monitoring at T0
Heart Rate at T1post induction heart rateheart rate monitoring at T1
Heart Rate at T215 minutes after inductionheart rate monitoring at T2
Heart Rate at T330 minutes after inductionheart rate monitoring at T3
Heart Rate at T460 minutes after inductionheart rate monitoring at T4
Heart Rate at T5120 minutes after inductionheart rate monitoring at T5
Heart Rate at T6post operative period after 30 min in post anaesthesia care unitheart rate monitoring at T6
Systolic Blood Pressure at T015 min before inductionsystolic blood pressure measurement at T0
Systolic Blood Pressure at T1post inductionsystolic blood pressure measurement at T1
Systolic Blood Pressure at T215 min after inductionsystolic blood pressure measurement at T2
Systolic Blood Pressure at T330 min after inductionsystolic blood pressure measurement at T3
Systolic Blood Pressure at T460 min after inductionsystolic blood pressure measurement at T4
Systolic Blood Pressure at T5120 min after inductionsystolic blood pressure measurement at T5
Systolic Blood Pressure at T6post operative period 30 min in post asnaesthesia care unitsystolic blood pressure measurement at T6
Diastolic Blood Presure at T015 minutes before inductionDiastolic blood pressure measurement at T0
Diastolic Blood Pressure at T1immediately after inductionDiastolic blood pressure measurement at T1
Diastolic Blood Pressure at T215 minutes after inductionDiastolic blood pressure measurement at T2
Diastolic Blood Pressure at T330 minutes after inductionDiastolic blood pressure measurement at T3
Diastolic Blood Pressure at T460 minutes after inductionDiastolic blood pressure measurement at T4
Diastolic Blood Pressure at T5120 minutes after inductionDiastolic blood pressure measurement at T5
Diastolic Blood Pressure at T6post induction 30 min in post anaesthesia care unitDiastolic blood pressure measurement at T6
Mean Blood Pressure at T015 minutes pre inductionMean blood pressure measurement at T0
Mean Blood Pressure at T1immediately after inductionMean blood pressure measurement at T1
Mean Blood Pressure at T215 minutes after inductionMean blood pressure measurement at T2
Mean Blood Pressure at T330 minutes after inductionMean blood pressure measurement at T3
Mean Blood Pressure at T460 minutes after inductionMean blood pressure measurement at T4
Mean Blood Pressure at T5120 minutes after inductionMean blood pressure measurement at T5
Mean Blood Pressure at T6post operative 30 min in post anaesthesia care unitMean blood pressure measurement at T6
Femoral Vein Velocity at T015 minutes pre inductionFemoral vein velocity measuement at T0
Femoral Vein Velocity at T215 minutes after inductionFemoral vein velocity measurement at T2
Femoral Vein Velocity at T6after 30 minutes in post anaesthesia care unitFemoral vein velocity measurement at T6
Femoral Vein Velocity Variance15 minutes pre induction to 30 minutes in post anaesthesia care unitthe variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage
Femoral Artery Velocity at T015 minutes pre inductionFemoral artery velocity measurement at T0
Femoral Artery Velocity at T215 minutes after inductionFemoral artery velocity measurement at T2
Femoral Artery Velocity at T6after 30 minutes in post anaesthesia care unitFemoral artery velocity measurement at T6
Inferior Venacava Diameter (Maximum) at T015 min pre inductioninferior venacava diameter (maximum) meaurement at T0
Inferior Venacava Diameter (Maximum) at T215 min after inductioninferior venacava diameter (maximum) meaurement at T2
Inferior Venacava Diameter (Maximum) at T6after 30 min in post anaesthesia care unitinferior venacava diameter (maximum) meaurement at T6
Inferior Venacava Diameter (Minimum) at T015 min pre inductioninferior venacava diameter (minimum) meaurement at T0
Inferior Venacava Diameter (Minimum) at T215 min after inductioninferior venacava diameter (minimum) meaurement at T2
Inferior Venacava Diameter (Minimum) at T6after 30 min in post anaesthesia care unitinferior venacava diameter (minimum) meaurement at T6
Inferior Venacava Diameter Collapsibility Index at T015 min pre inductionthe collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
Inferior Venacava Diameter Distensibility Index at T215 min after inductionthe inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .
Inferior Venacava Diameter Collapsibility Index at T6after 30 minutes in post anaesthesia care unitthe collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients
FLUID REQUIREMENT (Cumulative)operative periodfluid requirement (cumulative) during the operative period.
Blood Loss During OperationDuring operating procedureTotal blood loss during operation

Participant flow

Recruitment details

The study was conducted from January 2017 to July 2018 at ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RISHIKESH,UTTARAKHAND ,INDIA.

Participants by arm

ArmCount
Group A
No intervention was done ,served as a control group.
30
Group B
Intervention:peristaltic pneumatic compression device was placed on the legs of the patient and was active. HUNTLEIGH FLOWTRON ACS900 calf length device was used. HUNTLEIGH FLOWTRON ACS900
30
Total60

Baseline characteristics

CharacteristicGroup AGroup BTotal
Age, Continuous36.4 years
STANDARD_DEVIATION 9.4
34.1 years
STANDARD_DEVIATION 7.6
35.2 years
STANDARD_DEVIATION 8.5
Body Mass Index (BMI)22.8 kg^m2
STANDARD_DEVIATION 3.74
24.5 kg^m2
STANDARD_DEVIATION 4.2
23.65 kg^m2
STANDARD_DEVIATION 3.97
Height1.62 meters
STANDARD_DEVIATION 0.1
1.59 meters
STANDARD_DEVIATION 0.1
1.60 meters
STANDARD_DEVIATION 0.1
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
19 Participants18 Participants37 Participants
Sex: Female, Male
Male
11 Participants12 Participants23 Participants
Weight60.77 kilograms
STANDARD_DEVIATION 8.73
62.13 kilograms
STANDARD_DEVIATION 9.1
61.45 kilograms
STANDARD_DEVIATION 8.91

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 30
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

Blood Loss During Operation

Total blood loss during operation

Time frame: During operating procedure

ArmMeasureValue (MEAN)Dispersion
Group ABlood Loss During Operation99.67 millilitersStandard Deviation 50.34
Group BBlood Loss During Operation116.67 millilitersStandard Deviation 41.8
p-value: 0.16t-test, 2 sided
Primary

Diastolic Blood Pressure at T1

Diastolic blood pressure measurement at T1

Time frame: immediately after induction

ArmMeasureValue (MEAN)Dispersion
Group ADiastolic Blood Pressure at T166.30 millimeters of mercuryStandard Deviation 12.93
Group BDiastolic Blood Pressure at T169.33 millimeters of mercuryStandard Deviation 11.96
p-value: 0.35t-test, 2 sided
Primary

Diastolic Blood Pressure at T2

Diastolic blood pressure measurement at T2

Time frame: 15 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group ADiastolic Blood Pressure at T265.37 millimeters of mercuryStandard Deviation 11.66
Group BDiastolic Blood Pressure at T266.53 millimeters of mercuryStandard Deviation 12.29
p-value: 0.708t-test, 2 sided
Primary

Diastolic Blood Pressure at T3

Diastolic blood pressure measurement at T3

Time frame: 30 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group ADiastolic Blood Pressure at T369.46 millimeters of mercuryStandard Deviation 15.42
Group BDiastolic Blood Pressure at T368.13 millimeters of mercuryStandard Deviation 12.15
p-value: 0.711t-test, 2 sided
Primary

Diastolic Blood Pressure at T4

Diastolic blood pressure measurement at T4

Time frame: 60 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group ADiastolic Blood Pressure at T469.36 millimeters of mercuryStandard Deviation 16.75
Group BDiastolic Blood Pressure at T469.16 millimeters of mercuryStandard Deviation 10.56
p-value: 0.956t-test, 2 sided
Primary

Diastolic Blood Pressure at T5

Diastolic blood pressure measurement at T5

Time frame: 120 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group ADiastolic Blood Pressure at T566.63 millimeters of mercuryStandard Deviation 11.53
Group BDiastolic Blood Pressure at T570.80 millimeters of mercuryStandard Deviation 9.93
p-value: 0.139t-test, 2 sided
Primary

Diastolic Blood Pressure at T6

Diastolic blood pressure measurement at T6

Time frame: post induction 30 min in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group ADiastolic Blood Pressure at T670.66 millimeters of mercuryStandard Deviation 9.8
Group BDiastolic Blood Pressure at T675.80 millimeters of mercuryStandard Deviation 8.58
p-value: 0.035t-test, 2 sided
Primary

Diastolic Blood Presure at T0

Diastolic blood pressure measurement at T0

Time frame: 15 minutes before induction

ArmMeasureValue (MEAN)Dispersion
Group ADiastolic Blood Presure at T076.00 millimeters of mercuryStandard Deviation 11.66
Group BDiastolic Blood Presure at T072.23 millimeters of mercuryStandard Deviation 13.3
p-value: 0.704t-test, 2 sided
Primary

Femoral Artery Velocity at T0

Femoral artery velocity measurement at T0

Time frame: 15 minutes pre induction

ArmMeasureValue (MEAN)Dispersion
Group AFemoral Artery Velocity at T069.15 centimeters per secondStandard Deviation 14.08
Group BFemoral Artery Velocity at T076.25 centimeters per secondStandard Deviation 13.39
p-value: 0.03t-test, 2 sided
Primary

Femoral Artery Velocity at T2

Femoral artery velocity measurement at T2

Time frame: 15 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AFemoral Artery Velocity at T267.74 centimeters per secondStandard Deviation 11.96
Group BFemoral Artery Velocity at T273.91 centimeters per secondStandard Deviation 11.62
p-value: 0.048t-test, 2 sided
Primary

Femoral Artery Velocity at T6

Femoral artery velocity measurement at T6

Time frame: after 30 minutes in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AFemoral Artery Velocity at T669.82 centimeters per secondStandard Deviation 11.78
Group BFemoral Artery Velocity at T676.63 centimeters per secondStandard Deviation 14.07
p-value: 0.047t-test, 2 sided
Primary

Femoral Vein Velocity at T0

Femoral vein velocity measuement at T0

Time frame: 15 minutes pre induction

ArmMeasureValue (MEAN)Dispersion
Group AFemoral Vein Velocity at T029.35 centimeters per secondStandard Deviation 4.2
Group BFemoral Vein Velocity at T031.31 centimeters per secondStandard Deviation 7.28
p-value: 0.207t-test, 2 sided
Primary

Femoral Vein Velocity at T2

Femoral vein velocity measurement at T2

Time frame: 15 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AFemoral Vein Velocity at T227.79 centimeters per secondStandard Deviation 4.02
Group BFemoral Vein Velocity at T233.61 centimeters per secondStandard Deviation 7.61
p-value: 0.142t-test, 2 sided
Primary

Femoral Vein Velocity at T6

Femoral vein velocity measurement at T6

Time frame: after 30 minutes in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AFemoral Vein Velocity at T628.35 centimeters per secondStandard Deviation 5.64
Group BFemoral Vein Velocity at T631.92 centimeters per secondStandard Deviation 5.96
p-value: 0.021t-test, 2 sided
Primary

Femoral Vein Velocity Variance

the variance in femoral vein velocity was calculated by subtracting the femoral vein velocity pre induction from femoral vein velocity 15 min after induction divided by mean of the two values in percentage

Time frame: 15 minutes pre induction to 30 minutes in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AFemoral Vein Velocity Variance-5.419 percentage of velocityStandard Deviation 8.444
Group BFemoral Vein Velocity Variance7.188 percentage of velocityStandard Deviation 5.385
p-value: 0.0001t-test, 2 sided
Primary

FLUID REQUIREMENT (Cumulative)

fluid requirement (cumulative) during the operative period.

Time frame: operative period

Population: the population is same as the assigned population.

ArmMeasureValue (MEAN)Dispersion
Group AFLUID REQUIREMENT (Cumulative)1456.67 millilitersStandard Deviation 307.87
Group BFLUID REQUIREMENT (Cumulative)1291.66 millilitersStandard Deviation 320.04
p-value: 0.043t-test, 2 sided
Primary

Heart Rate at T0

heart rate monitoring at T0

Time frame: 15 minutes pre induction

ArmMeasureValue (MEAN)Dispersion
Group AHeart Rate at T085.23 beats per minuteStandard Deviation 17.81
Group BHeart Rate at T088.833 beats per minuteStandard Deviation 18.28
p-value: 0.443t-test, 2 sided
Primary

Heart Rate at T1

heart rate monitoring at T1

Time frame: post induction heart rate

ArmMeasureValue (MEAN)Dispersion
Group AHeart Rate at T179.60 beats per minuteStandard Deviation 16.44
Group BHeart Rate at T188.13 beats per minuteStandard Deviation 18.35
p-value: 0.063t-test, 2 sided
Primary

Heart Rate at T2

heart rate monitoring at T2

Time frame: 15 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AHeart Rate at T279.97 beats per minuteStandard Deviation 13.26
Group BHeart Rate at T288.57 beats per minuteStandard Deviation 20.3
p-value: 0.057t-test, 2 sided
Primary

Heart Rate at T3

heart rate monitoring at T3

Time frame: 30 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AHeart Rate at T376.70 beats per minuteStandard Deviation 12.26
Group BHeart Rate at T384.77 beats per minuteStandard Deviation 16.8
p-value: 0.038t-test, 2 sided
Primary

Heart Rate at T4

heart rate monitoring at T4

Time frame: 60 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AHeart Rate at T477.40 beats per minuteStandard Deviation 10.93
Group BHeart Rate at T483.56 beats per minuteStandard Deviation 14.83
p-value: 0.072t-test, 2 sided
Primary

Heart Rate at T5

heart rate monitoring at T5

Time frame: 120 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AHeart Rate at T577.53 beats per minuteStandard Deviation 12.71
Group BHeart Rate at T582.17 beats per minuteStandard Deviation 14.22
p-value: 0.189t-test, 2 sided
Primary

Heart Rate at T6

heart rate monitoring at T6

Time frame: post operative period after 30 min in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AHeart Rate at T685.06 beats per minuteStandard Deviation 12.58
Group BHeart Rate at T688.23 beats per minuteStandard Deviation 13.87
p-value: 0.358t-test, 2 sided
Primary

Inferior Venacava Diameter Collapsibility Index at T0

the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients

Time frame: 15 min pre induction

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter Collapsibility Index at T09.06 percentage of diameterStandard Deviation 4.17
Group BInferior Venacava Diameter Collapsibility Index at T09.32 percentage of diameterStandard Deviation 1.62
p-value: 0.746t-test, 2 sided
Primary

Inferior Venacava Diameter Collapsibility Index at T6

the collapsibility index was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by mean of the two diameters multiplied by 100.This was done for pre induction spontaneously breathing patients

Time frame: after 30 minutes in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter Collapsibility Index at T67.04 percentage of diameterStandard Deviation 3.46
Group BInferior Venacava Diameter Collapsibility Index at T610.03 percentage of diameterStandard Deviation 4.1
p-value: 0.003t-test, 2 sided
Primary

Inferior Venacava Diameter Distensibility Index at T2

the inferior venacava distensibility index for post induction mechanically ventilated patients. It was calculated by dividing the difference of maximum inferior vena cava diameter and minimum inferior vena cava diameter by minimum inferior vena cava diameters multiplied by 100 .

Time frame: 15 min after induction

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter Distensibility Index at T211.05 percentage of diameterStandard Deviation 4.17
Group BInferior Venacava Diameter Distensibility Index at T28.39 percentage of diameterStandard Deviation 2.841
p-value: 0.006t-test, 2 sided
Primary

Inferior Venacava Diameter (Maximum) at T0

inferior venacava diameter (maximum) meaurement at T0

Time frame: 15 min pre induction

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter (Maximum) at T01.16 centimetersStandard Deviation 0.14
Group BInferior Venacava Diameter (Maximum) at T01.26 centimetersStandard Deviation 0.17
p-value: 0.019t-test, 2 sided
Primary

Inferior Venacava Diameter (Maximum) at T2

inferior venacava diameter (maximum) meaurement at T2

Time frame: 15 min after induction

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter (Maximum) at T21.27 centimetersStandard Deviation 0.11
Group BInferior Venacava Diameter (Maximum) at T21.27 centimetersStandard Deviation 0.17
p-value: 0t-test, 2 sided
Primary

Inferior Venacava Diameter (Maximum) at T6

inferior venacava diameter (maximum) meaurement at T6

Time frame: after 30 min in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter (Maximum) at T61.19 centimetersStandard Deviation 0.13
Group BInferior Venacava Diameter (Maximum) at T61.31 centimetersStandard Deviation 0.17
p-value: 0.004t-test, 2 sided
Primary

Inferior Venacava Diameter (Minimum) at T0

inferior venacava diameter (minimum) meaurement at T0

Time frame: 15 min pre induction

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter (Minimum) at T01.06 centimetersStandard Deviation 0.13
Group BInferior Venacava Diameter (Minimum) at T01.15 centimetersStandard Deviation 0.15
p-value: 0.02t-test, 2 sided
Primary

Inferior Venacava Diameter (Minimum) at T2

inferior venacava diameter (minimum) meaurement at T2

Time frame: 15 min after induction

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter (Minimum) at T21.02 centimetersStandard Deviation 0.09
Group BInferior Venacava Diameter (Minimum) at T21.15 centimetersStandard Deviation 0.15
p-value: 0t-test, 2 sided
Primary

Inferior Venacava Diameter (Minimum) at T6

inferior venacava diameter (minimum) meaurement at T6

Time frame: after 30 min in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AInferior Venacava Diameter (Minimum) at T61.11 centimetersStandard Deviation 0.13
Group BInferior Venacava Diameter (Minimum) at T61.18 centimetersStandard Deviation 0.17
p-value: 0.053t-test, 2 sided
Primary

Mean Blood Pressure at T0

Mean blood pressure measurement at T0

Time frame: 15 minutes pre induction

ArmMeasureValue (MEAN)Dispersion
Group AMean Blood Pressure at T090.04 millimeters of mercuryStandard Deviation 11.03
Group BMean Blood Pressure at T092.19 millimeters of mercuryStandard Deviation 13.43
p-value: 0.502t-test, 2 sided
Primary

Mean Blood Pressure at T1

Mean blood pressure measurement at T1

Time frame: immediately after induction

ArmMeasureValue (MEAN)Dispersion
Group AMean Blood Pressure at T178.38 millimeters of mercuryStandard Deviation 13.29
Group BMean Blood Pressure at T181.82 millimeters of mercuryStandard Deviation 11.89
p-value: 0.35t-test, 2 sided
Primary

Mean Blood Pressure at T2

Mean blood pressure measurement at T2

Time frame: 15 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AMean Blood Pressure at T277.38 millimeters of mercuryStandard Deviation 11.46
Group BMean Blood Pressure at T279.99 millimeters of mercuryStandard Deviation 11.41
p-value: 0.38t-test, 2 sided
Primary

Mean Blood Pressure at T3

Mean blood pressure measurement at T3

Time frame: 30 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AMean Blood Pressure at T382.42 millimeters of mercuryStandard Deviation 14.36
Group BMean Blood Pressure at T382.05 millimeters of mercuryStandard Deviation 11.57
p-value: 0.914t-test, 2 sided
Primary

Mean Blood Pressure at T4

Mean blood pressure measurement at T4

Time frame: 60 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AMean Blood Pressure at T483.55 millimeters of mercuryStandard Deviation 15.79
Group BMean Blood Pressure at T483.19 millimeters of mercuryStandard Deviation 10.14
p-value: 0.915t-test, 2 sided
Primary

Mean Blood Pressure at T5

Mean blood pressure measurement at T5

Time frame: 120 minutes after induction

ArmMeasureValue (MEAN)Dispersion
Group AMean Blood Pressure at T581.16 millimeters of mercuryStandard Deviation 10.64
Group BMean Blood Pressure at T585.76 millimeters of mercuryStandard Deviation 9.78
p-value: 0.087t-test, 2 sided
Primary

Mean Blood Pressure at T6

Mean blood pressure measurement at T6

Time frame: post operative 30 min in post anaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group AMean Blood Pressure at T686.71 millimeters of mercuryStandard Deviation 8.98
Group BMean Blood Pressure at T692.54 millimeters of mercuryStandard Deviation 8.27
p-value: 0.011t-test, 2 sided
Primary

Systolic Blood Pressure at T0

systolic blood pressure measurement at T0

Time frame: 15 min before induction

ArmMeasureValue (MEAN)Dispersion
Group ASystolic Blood Pressure at T0119.06 millimeters of mercuryStandard Deviation 11.71
Group BSystolic Blood Pressure at T0122.1 millimeters of mercuryStandard Deviation 16.01
p-value: 0.406t-test, 2 sided
Primary

Systolic Blood Pressure at T1

systolic blood pressure measurement at T1

Time frame: post induction

ArmMeasureValue (MEAN)Dispersion
Group ASystolic Blood Pressure at T1102.33 millimeters of mercuryStandard Deviation 15.31
Group BSystolic Blood Pressure at T1106.80 millimeters of mercuryStandard Deviation 14.82
p-value: 0.256t-test, 2 sided
Primary

Systolic Blood Pressure at T2

systolic blood pressure measurement at T2

Time frame: 15 min after induction

ArmMeasureValue (MEAN)Dispersion
Group ASystolic Blood Pressure at T2100.73 millimeters of mercuryStandard Deviation 12.12
Group BSystolic Blood Pressure at T2106.93 millimeters of mercuryStandard Deviation 13.45
p-value: 0.066t-test, 2 sided
Primary

Systolic Blood Pressure at T3

systolic blood pressure measurement at T3

Time frame: 30 min after induction

ArmMeasureValue (MEAN)Dispersion
Group ASystolic Blood Pressure at T3106.23 millimeters of mercuryStandard Deviation 15.08
Group BSystolic Blood Pressure at T3109.90 millimeters of mercuryStandard Deviation 12.93
p-value: 0.316t-test, 2 sided
Primary

Systolic Blood Pressure at T4

systolic blood pressure measurement at T4

Time frame: 60 min after induction

ArmMeasureValue (MEAN)Dispersion
Group ASystolic Blood Pressure at T4111.10 millimeters of mercuryStandard Deviation 15.59
Group BSystolic Blood Pressure at T4111.23 millimeters of mercuryStandard Deviation 12.45
p-value: 0.971t-test, 2 sided
Primary

Systolic Blood Pressure at T5

systolic blood pressure measurement at T5

Time frame: 120 min after induction

ArmMeasureValue (MEAN)Dispersion
Group ASystolic Blood Pressure at T5108.86 millimeters of mercuryStandard Deviation 10.92
Group BSystolic Blood Pressure at T5115.70 millimeters of mercuryStandard Deviation 12.79
p-value: 0.03t-test, 2 sided
Primary

Systolic Blood Pressure at T6

systolic blood pressure measurement at T6

Time frame: post operative period 30 min in post asnaesthesia care unit

ArmMeasureValue (MEAN)Dispersion
Group ASystolic Blood Pressure at T6118.80 millimeters of mercuryStandard Deviation 10.34
Group BSystolic Blood Pressure at T6126.03 millimeters of mercuryStandard Deviation 10.49
p-value: 0.009t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026