Trial Outcomes & Findings for Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position (NCT NCT02249585)
NCT ID: NCT02249585
Last Updated: 2018-08-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
30 min after onset of laparoscopy
Results posted on
2018-08-06
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
44
|
|
Overall Study
COMPLETED
|
43
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position
Baseline characteristics by cohort
| Measure |
CS(Conventional Block With Standard Pressure)
n=43 Participants
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
|
DS(Deep Block With Standard Pressure)
n=44 Participants
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
|
DL(Deep Block With Low Pressure)
n=44 Participants
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
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 12 • n=5 Participants
|
64 years
STANDARD_DEVIATION 11 • n=7 Participants
|
62 years
STANDARD_DEVIATION 11 • n=5 Participants
|
65 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 min after onset of laparoscopyCardiac 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.
Outcome measures
| Measure |
CS(Conventional Block With Standard Pressure)
n=43 Participants
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
|
DS(Deep Block With Standard Pressure)
n=44 Participants
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
|
DL(Deep Block With Low Pressure)
n=44 Participants
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
|
|---|---|---|---|
|
Cardiac Index
|
2.6 L/min/m^2
Standard Deviation 1.0
|
2.7 L/min/m^2
Standard Deviation 0.9
|
2.7 L/min/m^2
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 1, 30, 60, 90, and 120 minutes after onset of laparoscopyMean 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.
Outcome measures
| Measure |
CS(Conventional Block With Standard Pressure)
n=43 Participants
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
|
DS(Deep Block With Standard Pressure)
n=44 Participants
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
|
DL(Deep Block With Low Pressure)
n=44 Participants
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
|
|---|---|---|---|
|
Mean Arterial Blood Pressure (MBP)
MBP 1 min after onset of laparoscopy
|
88 mmHg
Standard Deviation 13
|
92 mmHg
Standard Deviation 12
|
90 mmHg
Standard Deviation 13
|
|
Mean Arterial Blood Pressure (MBP)
MBP 30 min after onset of laparoscopy
|
89 mmHg
Standard Deviation 10
|
92 mmHg
Standard Deviation 14
|
91 mmHg
Standard Deviation 12
|
|
Mean Arterial Blood Pressure (MBP)
MBP 60 min after onset of laparoscopy
|
88 mmHg
Standard Deviation 11
|
90 mmHg
Standard Deviation 14
|
89 mmHg
Standard Deviation 12
|
|
Mean Arterial Blood Pressure (MBP)
MBP 90 min after onset of laparoscopy
|
87 mmHg
Standard Deviation 11
|
89 mmHg
Standard Deviation 10
|
88 mmHg
Standard Deviation 11
|
|
Mean Arterial Blood Pressure (MBP)
MBP 120 min after onset of laparoscopy
|
87 mmHg
Standard Deviation 13
|
90 mmHg
Standard Deviation 10
|
88 mmHg
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 1, 30, 60, 90, 120 min after onset of laparoscopyStroke 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.
Outcome measures
| Measure |
CS(Conventional Block With Standard Pressure)
n=43 Participants
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
|
DS(Deep Block With Standard Pressure)
n=44 Participants
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
|
DL(Deep Block With Low Pressure)
n=44 Participants
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
|
|---|---|---|---|
|
Stroke Volume Index (SVI)
SVI 1 min after onset of laparoscopy
|
37 mL/beat/m^2
Standard Deviation 9
|
41 mL/beat/m^2
Standard Deviation 12
|
38 mL/beat/m^2
Standard Deviation 10
|
|
Stroke Volume Index (SVI)
SVI 30 min after onset of laparoscopy
|
38 mL/beat/m^2
Standard Deviation 10
|
42 mL/beat/m^2
Standard Deviation 12
|
40 mL/beat/m^2
Standard Deviation 11
|
|
Stroke Volume Index (SVI)
SVI 60 min after onset of laparoscopy
|
39 mL/beat/m^2
Standard Deviation 12
|
42 mL/beat/m^2
Standard Deviation 12
|
40 mL/beat/m^2
Standard Deviation 11
|
|
Stroke Volume Index (SVI)
SVI 90 min after onset of laparoscopy
|
38 mL/beat/m^2
Standard Deviation 9
|
41 mL/beat/m^2
Standard Deviation 11
|
39 mL/beat/m^2
Standard Deviation 10
|
|
Stroke Volume Index (SVI)
SVI 120 min after onset of laparoscopy
|
38 mL/beat/m^2
Standard Deviation 9
|
40 mL/beat/m^2
Standard Deviation 12
|
39 mL/beat/m^2
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 1, 30, 60, 90, and 120 minutes after onset of laparoscopyPaO2 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).
Outcome measures
| Measure |
CS(Conventional Block With Standard Pressure)
n=43 Participants
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
|
DS(Deep Block With Standard Pressure)
n=44 Participants
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
|
DL(Deep Block With Low Pressure)
n=44 Participants
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
|
|---|---|---|---|
|
PaO2
PaO2 1 min after onset of laparoscopy
|
25 kPa
Standard Deviation 7
|
26 kPa
Standard Deviation 7
|
27 kPa
Standard Deviation 7
|
|
PaO2
PaO2 30 min after onset of laparoscopy
|
25 kPa
Standard Deviation 7
|
26 kPa
Standard Deviation 6
|
27 kPa
Standard Deviation 7
|
|
PaO2
PaO2 60 min after onset of laparoscopy
|
25 kPa
Standard Deviation 6
|
26 kPa
Standard Deviation 7
|
26 kPa
Standard Deviation 7
|
|
PaO2
PaO2 90 min after onset of laparoscopy
|
27 kPa
Standard Deviation 6
|
28 kPa
Standard Deviation 5
|
25 kPa
Standard Deviation 6
|
|
PaO2
PaO2 120 min after onset of laparoscopy
|
27 kPa
Standard Deviation 6
|
28 kPa
Standard Deviation 5
|
25 kPa
Standard Deviation 7
|
SECONDARY outcome
Timeframe: 1, 30, 60, 90, and 120 minutes after onset of laparoscopyPulmonary 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).
Outcome measures
| Measure |
CS(Conventional Block With Standard Pressure)
n=43 Participants
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
|
DS(Deep Block With Standard Pressure)
n=44 Participants
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
|
DL(Deep Block With Low Pressure)
n=44 Participants
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
|
|---|---|---|---|
|
Pulmonary Compliance
Compliance 1 min after onset of laparoscop
|
29 mL/cmH2O
Standard Deviation 7
|
29 mL/cmH2O
Standard Deviation 9
|
34 mL/cmH2O
Standard Deviation 8
|
|
Pulmonary Compliance
Compliance 30 min after onset of laparoscop
|
24 mL/cmH2O
Standard Deviation 6
|
25 mL/cmH2O
Standard Deviation 5
|
28 mL/cmH2O
Standard Deviation 5
|
|
Pulmonary Compliance
Compliance 60 min after onset of laparoscop
|
25 mL/cmH2O
Standard Deviation 6
|
25 mL/cmH2O
Standard Deviation 6
|
29 mL/cmH2O
Standard Deviation 8
|
|
Pulmonary Compliance
Compliance 90 min after onset of laparoscop
|
26 mL/cmH2O
Standard Deviation 7
|
25 mL/cmH2O
Standard Deviation 8
|
28 mL/cmH2O
Standard Deviation 7
|
|
Pulmonary Compliance
Compliance 120 min after onset of laparoscop
|
28 mL/cmH2O
Standard Deviation 7
|
28 mL/cmH2O
Standard Deviation 6
|
30 mL/cmH2O
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 1 min after laparoscopic procedureThe surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.
Outcome measures
| Measure |
CS(Conventional Block With Standard Pressure)
n=43 Participants
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
|
DS(Deep Block With Standard Pressure)
n=44 Participants
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
|
DL(Deep Block With Low Pressure)
n=44 Participants
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
|
|---|---|---|---|
|
Surgical Rating Scale
Poor
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Surgical Rating Scale
Optimal
|
33 Participants
|
37 Participants
|
20 Participants
|
|
Surgical Rating Scale
Good
|
3 Participants
|
7 Participants
|
6 Participants
|
|
Surgical Rating Scale
Acceptable
|
7 Participants
|
0 Participants
|
10 Participants
|
|
Surgical Rating Scale
Extremely poor
|
0 Participants
|
0 Participants
|
4 Participants
|
Adverse Events
CS(Conventional Block With Standard Pressure)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DS(Deep Block With Standard Pressure)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DL(Deep Block With Low Pressure)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Kook Hyun Lee, MD, PhD
Seoul National University Hospital
Phone: 82-2-2072-2467
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place