Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position
- Conditions
- Cardiac Index
- Interventions
- Device: Standard abdominal pressureDevice: Low abdominal pressureDrug: Deep neuromuscular blockadeDrug: Conventional neuromuscular blockade
- Registration Number
- NCT02249585
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
- Patients scheduled for laparoscopic colon surgery under Trendelenberg position
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CS Standard abdominal pressure Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure. DL Deep neuromuscular blockade Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure. DS Deep neuromuscular blockade Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure. DS Standard abdominal pressure Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure. CS Conventional neuromuscular blockade Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure. DL Low abdominal pressure Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
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.
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of