Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS | Experimental | Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure. |
|
| DS | Experimental | Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure. |
|
| DL | Experimental | Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard abdominal pressure | Device | Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 min after onset of laparoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low abdominal pressure | Device | Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery |
|
|
| Conventional neuromuscular blockade | Drug | Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch |
|
| Deep neuromuscular blockade | Drug | Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch |
|
| 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. | 1, 30, 60, 90, 120 min after onset of laparoscopy |
| 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). | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy |
| 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). | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy |
| 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. | 1 min after laparoscopic procedure |
| FG001 | 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 |
| FG002 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | L/min/m^2 | 30 min after onset of laparoscopy |
|
|
| ||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | mmHg | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy |
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | mL/beat/m^2 | 1, 30, 60, 90, 120 min after onset of laparoscopy |
| ||||||||||||||||||||||||||||||||||
| 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). | Posted | Mean | Standard Deviation | kPa | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy |
| ||||||||||||||||||||||||||||||||||
| 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). | Posted | Mean | Standard Deviation | mL/cmH2O | 1, 30, 60, 90, and 120 minutes after onset of laparoscopy |
| ||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | No | 1 min after laparoscopic procedure |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 43 | 0 | 43 | ||
| EG001 | 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 | 0 | 44 | 0 | 44 | ||
| EG002 | 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 | 0 | 44 | 0 | 44 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kook Hyun Lee, MD, PhD | Seoul National University Hospital | 82-2-2072-2467 | leekh@snu.ac.kr |
| ID | Term |
|---|---|
| D008150 | Lower Body Negative Pressure |
| ID | Term |
|---|---|
| D003664 | Decompression |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
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 |
|
|
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
|
|
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
|
|
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 |
|
|
|
|