Cardiac Index
Conditions
Brief summary
The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.
Interventions
DEVICEStandard abdominal pressure
Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery
DEVICELow abdominal pressure
Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery
DRUGConventional neuromuscular blockade
Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch
Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for laparoscopic colon surgery under Trendelenberg position
Exclusion criteria
* ASA classification IV * Unable to make a written, informed consent * Allergic to neuromuscular blocking agents, anesthetics, opioids * Patients with neuromuscular disease * Hepatic failure * Renal failure * History of malignant hyperthermia * Morbid obesity with BMI\>35 kg/m2 * Patients enrolled in another clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Index | 30 min after onset of laparoscopy | Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Blood Pressure (MBP) | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy | Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery. |
| Stroke Volume Index (SVI) | 1, 30, 60, 90, 120 min after onset of laparoscopy | Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery. |
| PaO2 | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy | PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA). |
| Pulmonary Compliance | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy | Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany). |
| Surgical Rating Scale | 1 min after laparoscopic procedure | The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CS(Conventional Block With Standard Pressure) Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery
Conventional neuromuscular blockade: Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch | 43 |
| DS(Deep Block With Standard Pressure) Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
Standard abdominal pressure: Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch | 44 |
| DL(Deep Block With Low Pressure) Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
Low abdominal pressure: Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery
Deep neuromuscular blockade: Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch | 44 |
| Total | 131 |
Baseline characteristics
| Characteristic | CS(Conventional Block With Standard Pressure) | DS(Deep Block With Standard Pressure) | DL(Deep Block With Low Pressure) | Total |
|---|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 12 | 64 years STANDARD_DEVIATION 11 | 62 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 12 |
| Region of Enrollment South Korea | 43 Participants | 44 Participants | 44 Participants | 131 Participants |
| Sex: Female, Male Female | 25 Participants | 27 Participants | 28 Participants | 80 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 16 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 43 | 0 / 44 | 0 / 44 |
Outcome results
Primary
Cardiac Index
Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
Time frame: 30 min after onset of laparoscopy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CS(Conventional Block With Standard Pressure) | Cardiac Index | 2.6 L/min/m^2 | Standard Deviation 1 |
| DS(Deep Block With Standard Pressure) | Cardiac Index | 2.7 L/min/m^2 | Standard Deviation 0.9 |
| DL(Deep Block With Low Pressure) | Cardiac Index | 2.7 L/min/m^2 | Standard Deviation 0.7 |
Secondary
Mean Arterial Blood Pressure (MBP)
Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CS(Conventional Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 90 min after onset of laparoscopy | 87 mmHg | Standard Deviation 11 |
| CS(Conventional Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 60 min after onset of laparoscopy | 88 mmHg | Standard Deviation 11 |
| CS(Conventional Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 1 min after onset of laparoscopy | 88 mmHg | Standard Deviation 13 |
| CS(Conventional Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 30 min after onset of laparoscopy | 89 mmHg | Standard Deviation 10 |
| CS(Conventional Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 120 min after onset of laparoscopy | 87 mmHg | Standard Deviation 13 |
| DS(Deep Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 60 min after onset of laparoscopy | 90 mmHg | Standard Deviation 14 |
| DS(Deep Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 1 min after onset of laparoscopy | 92 mmHg | Standard Deviation 12 |
| DS(Deep Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 30 min after onset of laparoscopy | 92 mmHg | Standard Deviation 14 |
| DS(Deep Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 90 min after onset of laparoscopy | 89 mmHg | Standard Deviation 10 |
| DS(Deep Block With Standard Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 120 min after onset of laparoscopy | 90 mmHg | Standard Deviation 10 |
| DL(Deep Block With Low Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 120 min after onset of laparoscopy | 88 mmHg | Standard Deviation 13 |
| DL(Deep Block With Low Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 90 min after onset of laparoscopy | 88 mmHg | Standard Deviation 11 |
| DL(Deep Block With Low Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 1 min after onset of laparoscopy | 90 mmHg | Standard Deviation 13 |
| DL(Deep Block With Low Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 60 min after onset of laparoscopy | 89 mmHg | Standard Deviation 12 |
| DL(Deep Block With Low Pressure) | Mean Arterial Blood Pressure (MBP) | MBP 30 min after onset of laparoscopy | 91 mmHg | Standard Deviation 12 |
Secondary
PaO2
PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).
Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CS(Conventional Block With Standard Pressure) | PaO2 | PaO2 90 min after onset of laparoscopy | 27 kPa | Standard Deviation 6 |
| CS(Conventional Block With Standard Pressure) | PaO2 | PaO2 60 min after onset of laparoscopy | 25 kPa | Standard Deviation 6 |
| CS(Conventional Block With Standard Pressure) | PaO2 | PaO2 1 min after onset of laparoscopy | 25 kPa | Standard Deviation 7 |
| CS(Conventional Block With Standard Pressure) | PaO2 | PaO2 30 min after onset of laparoscopy | 25 kPa | Standard Deviation 7 |
| CS(Conventional Block With Standard Pressure) | PaO2 | PaO2 120 min after onset of laparoscopy | 27 kPa | Standard Deviation 6 |
| DS(Deep Block With Standard Pressure) | PaO2 | PaO2 60 min after onset of laparoscopy | 26 kPa | Standard Deviation 7 |
| DS(Deep Block With Standard Pressure) | PaO2 | PaO2 1 min after onset of laparoscopy | 26 kPa | Standard Deviation 7 |
| DS(Deep Block With Standard Pressure) | PaO2 | PaO2 30 min after onset of laparoscopy | 26 kPa | Standard Deviation 6 |
| DS(Deep Block With Standard Pressure) | PaO2 | PaO2 90 min after onset of laparoscopy | 28 kPa | Standard Deviation 5 |
| DS(Deep Block With Standard Pressure) | PaO2 | PaO2 120 min after onset of laparoscopy | 28 kPa | Standard Deviation 5 |
| DL(Deep Block With Low Pressure) | PaO2 | PaO2 120 min after onset of laparoscopy | 25 kPa | Standard Deviation 7 |
| DL(Deep Block With Low Pressure) | PaO2 | PaO2 90 min after onset of laparoscopy | 25 kPa | Standard Deviation 6 |
| DL(Deep Block With Low Pressure) | PaO2 | PaO2 1 min after onset of laparoscopy | 27 kPa | Standard Deviation 7 |
| DL(Deep Block With Low Pressure) | PaO2 | PaO2 60 min after onset of laparoscopy | 26 kPa | Standard Deviation 7 |
| DL(Deep Block With Low Pressure) | PaO2 | PaO2 30 min after onset of laparoscopy | 27 kPa | Standard Deviation 7 |
Secondary
Pulmonary Compliance
Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).
Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CS(Conventional Block With Standard Pressure) | Pulmonary Compliance | Compliance 90 min after onset of laparoscop | 26 mL/cmH2O | Standard Deviation 7 |
| CS(Conventional Block With Standard Pressure) | Pulmonary Compliance | Compliance 60 min after onset of laparoscop | 25 mL/cmH2O | Standard Deviation 6 |
| CS(Conventional Block With Standard Pressure) | Pulmonary Compliance | Compliance 1 min after onset of laparoscop | 29 mL/cmH2O | Standard Deviation 7 |
| CS(Conventional Block With Standard Pressure) | Pulmonary Compliance | Compliance 30 min after onset of laparoscop | 24 mL/cmH2O | Standard Deviation 6 |
| CS(Conventional Block With Standard Pressure) | Pulmonary Compliance | Compliance 120 min after onset of laparoscop | 28 mL/cmH2O | Standard Deviation 7 |
| DS(Deep Block With Standard Pressure) | Pulmonary Compliance | Compliance 60 min after onset of laparoscop | 25 mL/cmH2O | Standard Deviation 6 |
| DS(Deep Block With Standard Pressure) | Pulmonary Compliance | Compliance 1 min after onset of laparoscop | 29 mL/cmH2O | Standard Deviation 9 |
| DS(Deep Block With Standard Pressure) | Pulmonary Compliance | Compliance 30 min after onset of laparoscop | 25 mL/cmH2O | Standard Deviation 5 |
| DS(Deep Block With Standard Pressure) | Pulmonary Compliance | Compliance 90 min after onset of laparoscop | 25 mL/cmH2O | Standard Deviation 8 |
| DS(Deep Block With Standard Pressure) | Pulmonary Compliance | Compliance 120 min after onset of laparoscop | 28 mL/cmH2O | Standard Deviation 6 |
| DL(Deep Block With Low Pressure) | Pulmonary Compliance | Compliance 120 min after onset of laparoscop | 30 mL/cmH2O | Standard Deviation 8 |
| DL(Deep Block With Low Pressure) | Pulmonary Compliance | Compliance 90 min after onset of laparoscop | 28 mL/cmH2O | Standard Deviation 7 |
| DL(Deep Block With Low Pressure) | Pulmonary Compliance | Compliance 1 min after onset of laparoscop | 34 mL/cmH2O | Standard Deviation 8 |
| DL(Deep Block With Low Pressure) | Pulmonary Compliance | Compliance 60 min after onset of laparoscop | 29 mL/cmH2O | Standard Deviation 8 |
| DL(Deep Block With Low Pressure) | Pulmonary Compliance | Compliance 30 min after onset of laparoscop | 28 mL/cmH2O | Standard Deviation 5 |
Secondary
Stroke Volume Index (SVI)
Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.
Time frame: 1, 30, 60, 90, 120 min after onset of laparoscopy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CS(Conventional Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 90 min after onset of laparoscopy | 38 mL/beat/m^2 | Standard Deviation 9 |
| CS(Conventional Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 60 min after onset of laparoscopy | 39 mL/beat/m^2 | Standard Deviation 12 |
| CS(Conventional Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 1 min after onset of laparoscopy | 37 mL/beat/m^2 | Standard Deviation 9 |
| CS(Conventional Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 30 min after onset of laparoscopy | 38 mL/beat/m^2 | Standard Deviation 10 |
| CS(Conventional Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 120 min after onset of laparoscopy | 38 mL/beat/m^2 | Standard Deviation 9 |
| DS(Deep Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 60 min after onset of laparoscopy | 42 mL/beat/m^2 | Standard Deviation 12 |
| DS(Deep Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 1 min after onset of laparoscopy | 41 mL/beat/m^2 | Standard Deviation 12 |
| DS(Deep Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 30 min after onset of laparoscopy | 42 mL/beat/m^2 | Standard Deviation 12 |
| DS(Deep Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 90 min after onset of laparoscopy | 41 mL/beat/m^2 | Standard Deviation 11 |
| DS(Deep Block With Standard Pressure) | Stroke Volume Index (SVI) | SVI 120 min after onset of laparoscopy | 40 mL/beat/m^2 | Standard Deviation 12 |
| DL(Deep Block With Low Pressure) | Stroke Volume Index (SVI) | SVI 120 min after onset of laparoscopy | 39 mL/beat/m^2 | Standard Deviation 9 |
| DL(Deep Block With Low Pressure) | Stroke Volume Index (SVI) | SVI 90 min after onset of laparoscopy | 39 mL/beat/m^2 | Standard Deviation 10 |
| DL(Deep Block With Low Pressure) | Stroke Volume Index (SVI) | SVI 1 min after onset of laparoscopy | 38 mL/beat/m^2 | Standard Deviation 10 |
| DL(Deep Block With Low Pressure) | Stroke Volume Index (SVI) | SVI 60 min after onset of laparoscopy | 40 mL/beat/m^2 | Standard Deviation 11 |
| DL(Deep Block With Low Pressure) | Stroke Volume Index (SVI) | SVI 30 min after onset of laparoscopy | 40 mL/beat/m^2 | Standard Deviation 11 |
Secondary
Surgical Rating Scale
The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.
Time frame: 1 min after laparoscopic procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CS(Conventional Block With Standard Pressure) | Surgical Rating Scale | Poor | 0 Participants |
| CS(Conventional Block With Standard Pressure) | Surgical Rating Scale | Acceptable | 7 Participants |
| CS(Conventional Block With Standard Pressure) | Surgical Rating Scale | Optimal | 33 Participants |
| CS(Conventional Block With Standard Pressure) | Surgical Rating Scale | Good | 3 Participants |
| CS(Conventional Block With Standard Pressure) | Surgical Rating Scale | Extremely poor | 0 Participants |
| DS(Deep Block With Standard Pressure) | Surgical Rating Scale | Acceptable | 0 Participants |
| DS(Deep Block With Standard Pressure) | Surgical Rating Scale | Optimal | 37 Participants |
| DS(Deep Block With Standard Pressure) | Surgical Rating Scale | Good | 7 Participants |
| DS(Deep Block With Standard Pressure) | Surgical Rating Scale | Poor | 0 Participants |
| DS(Deep Block With Standard Pressure) | Surgical Rating Scale | Extremely poor | 0 Participants |
| DL(Deep Block With Low Pressure) | Surgical Rating Scale | Extremely poor | 4 Participants |
| DL(Deep Block With Low Pressure) | Surgical Rating Scale | Poor | 4 Participants |
| DL(Deep Block With Low Pressure) | Surgical Rating Scale | Optimal | 20 Participants |
| DL(Deep Block With Low Pressure) | Surgical Rating Scale | Acceptable | 10 Participants |
| DL(Deep Block With Low Pressure) | Surgical Rating Scale | Good | 6 Participants |