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Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position

Not Applicable
Completed
Conditions
Cardiac Index
Interventions
Device: Standard abdominal pressure
Device: Low abdominal pressure
Drug: Deep neuromuscular blockade
Drug: 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
Inclusion Criteria
  • Patients scheduled for laparoscopic colon surgery under Trendelenberg position
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CSStandard abdominal pressurePatients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
DLDeep neuromuscular blockadePatients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
DSDeep neuromuscular blockadePatients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
DSStandard abdominal pressurePatients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
CSConventional neuromuscular blockadePatients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
DLLow abdominal pressurePatients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
Primary Outcome Measures
NameTimeMethod
Cardiac Index30 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
NameTimeMethod
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.

PaO21, 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 Compliance1, 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 Scale1 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

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