| Registry | NCT02249585 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: triple, prevention |
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| Enrollment | 131 (Actual) |
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| Sponsor | Seoul National University Hospital (Other) |
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| Conditions | Cardiac Index |
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| Interventions | Standard abdominal pressure, Low abdominal pressure, Conventional neuromuscular blockade, Deep neuromuscular blockade (Device, drug) |
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| Dates | start 2014-09-01, primary completion 2016-10-01, completion 2016-10-01, first posted 2014-09-25, last updated 2018-08-06 |
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| Locations | 1 site in South Korea |
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Related Papers Related Patents Related Grants Related Experts
All trials for Cardiac Index All trials of Standard abdominal pressure All trials of Low abdominal pressure
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| CS | Experimental | Device: Standard abdominal pressure; Drug: Conventional neuromuscular blockade | Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure. |
| DS | Experimental | Device: Standard abdominal pressure; Drug: Deep neuromuscular blockade | Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure. |
| DL | Experimental | Device: Low abdominal pressure; Drug: Deep neuromuscular blockade | Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure. |
- Standard abdominal pressure (Device): Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery
- Low abdominal pressure (Device), also known as Abdominal pressure: 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
+Outcome measures
Primary outcomes
- 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 outcomes
- 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.
+Eligibility
Sex: All, ages: 20 Years to 90 Years
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
+Posted results
Participant flow
| Milestone | CS(Conventional Block With Standard Pressure) | DS(Deep Block With Standard Pressure) | DL(Deep Block With Low Pressure) |
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| Started | 43 | 44 | 44 |
| Completed | 43 | 44 | 44 |
| Not completed | 0 | 0 | 0 |
Outcome results
- Cardiac Index (Primary), Mean, L/min/m^2: CS(Conventional Block With Standard Pressure) 2.6 +/- 1.0; DS(Deep Block With Standard Pressure) 2.7 +/- 0.9; DL(Deep Block With Low Pressure) 2.7 +/- 0.7
- Mean Arterial Blood Pressure (MBP) (Secondary), Mean, mmHg: CS(Conventional Block With Standard Pressure) 88 +/- 13; DS(Deep Block With Standard Pressure) 92 +/- 12; DL(Deep Block With Low Pressure) 90 +/- 13
- Stroke Volume Index (SVI) (Secondary), Mean, mL/beat/m^2: CS(Conventional Block With Standard Pressure) 37 +/- 9; DS(Deep Block With Standard Pressure) 41 +/- 12; DL(Deep Block With Low Pressure) 38 +/- 10
- PaO2 (Secondary), Mean, kPa: CS(Conventional Block With Standard Pressure) 25 +/- 7; DS(Deep Block With Standard Pressure) 26 +/- 7; DL(Deep Block With Low Pressure) 27 +/- 7
- Pulmonary Compliance (Secondary), Mean, mL/cmH2O: CS(Conventional Block With Standard Pressure) 29 +/- 7; DS(Deep Block With Standard Pressure) 29 +/- 9; DL(Deep Block With Low Pressure) 34 +/- 8
- Surgical Rating Scale (Secondary), Count of participants, Participants: CS(Conventional Block With Standard Pressure) 33; DS(Deep Block With Standard Pressure) 37; DL(Deep Block With Low Pressure) 20
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| CS(Conventional Block With Standard Pressure) | 0 | 0/43 (0.0%) | 0/43 (0.0%) |
| DS(Deep Block With Standard Pressure) | 0 | 0/44 (0.0%) | 0/44 (0.0%) |
| DL(Deep Block With Low Pressure) | 0 | 0/44 (0.0%) | 0/44 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Seoul National University Hospital | Seoul | South Korea | |