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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

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ClinicalTrials.gov Identifier: NCT02249585
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kook Hyun Lee, Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Index Device: Standard abdominal pressure Device: Low abdominal pressure Drug: Conventional neuromuscular blockade Drug: Deep neuromuscular blockade Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: CS
Patients who receive laparoscopic colon surgery under Trendelenberg position with conventional neuromuscular blockade and standard abdominal pressure.
 Device: Standard abdominal pressure
Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery

Drug: Conventional neuromuscular blockade
Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch
Experimental: DS
Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and standard abdominal pressure.
 Device: Standard abdominal pressure
Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery

Drug: Deep neuromuscular blockade
Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch
Experimental: DL
Patients who receive laparoscopic colon surgery under Trendelenberg position with deep neuromuscular blockade and low abdominal pressure.
 Device: Low abdominal pressure
Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery
Other Name: Abdominal pressure

Drug: Deep neuromuscular blockade
Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac Index [ Time Frame: 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 :
  1. Mean Arterial Blood Pressure (MBP) [ Time Frame: 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.

  2. Stroke Volume Index (SVI) [ Time Frame: 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.

  3. PaO2 [ Time Frame: 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).

  4. Pulmonary Compliance [ Time Frame: 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).

  5. Surgical Rating Scale [ Time Frame: 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 Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249585


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Kook Hyun Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02249585    
Other Study ID Numbers: 1405-010-576
First Posted: September 25, 2014    Key Record Dates
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018
Last Verified: November 2017
Additional relevant MeSH terms:
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Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
 Trace Elements
Micronutrients
Physiological Effects of Drugs