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Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.

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ClinicalTrials.gov Identifier: NCT02025075
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marcos Vidal Melo, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE December 19, 2013
First Posted Date  ICMJE December 31, 2013
Results First Submitted Date  ICMJE March 9, 2017
Results First Posted Date  ICMJE May 30, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
  • Regional Change in Air Content (Delta Z, %) [ Time Frame: BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum ]
    We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6). Percent change was calculated using electrical impedance measurements obtained at time T0 as reference.
  • Ejection Fraction (%) [ Time Frame: BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum ]
    To assess cardiac performance, transthoracic echocardiography will be used. Ejection fraction was measured as fractional shortening (FS). FS is the fraction of any diastolic dimension that is lost in systole. FS = 100*(LVEDD - LVESD) / LVEDD, LVEDD = LV end-diastolic dimension (mm); LVESD = LV end-systolic dimension (mm).
  • Cerebral Oximetry (%) [ Time Frame: BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum ]
    Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2013)
  • Ejection Fraction (%) [ Time Frame: The outcome measure will be assessed intraoperatively following introduction of pneumoperitoneum and positioning as the change from the conditions of deep to the condition of mild muscle relaxation as defined by TOF and post-tetanic twitches. ]
    To assess cardiac performance, transthoracic echocardiography will be used.
  • Regional Change in Air Content (Delta Z, %) [ Time Frame: The outcome measure will be assessed intraoperatively following introduction of pneumoperitoneum and positioning as the change from the conditions of deep to the condition of mild muscle relaxation as defined by TOF and post-tetanic twitches. ]
    We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6).
  • Cerebral Oximetry (%) [ Time Frame: The outcome measure will be assessed intraoperatively following introduction of pneumoperitoneum and positioning as the change from the conditions of deep to the condition of mild muscle relaxation as defined by TOF and post-tetanic twitches. ]
    Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
Postoperative Pain [ Time Frame: Postoperative Day 1 ]
The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as incisional pain using VAS (0 = no pain; 100 = worst possible pain).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2013)
Postoperative Pain [ Time Frame: Postoperative Day 1 ]
The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as abdominal pain, incisional pain, shoulder pain and overall pain using VAS (0 = no pain; 100 = worst possible pain).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.
Official Title  ICMJE A Prospective, Double-blind, Randomized, Crossover Design Study to Compare the Hemodynamic and Respiratory Variations During Laparoscopic Surgery in Patients With and Without Deep Neuromuscular Blockade.
Brief Summary The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences intraoperative hemodynamic and cerebral oxygenation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Intraoperative Complications
  • Postoperative Complications
  • Laparoscopy
  • Surgical Complications From General Anesthesia
  • Ventilator-Induced Lung Injury
Intervention  ICMJE Drug: Rocuronium
Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).
Other Name: Zemuron
Study Arms  ICMJE
  • Experimental: Deep Neuromuscular Block (NMB)
    Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).
    Intervention: Drug: Rocuronium
  • Active Comparator: Moderate Neuromuscular block (NMB)
    Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).
    Intervention: Drug: Rocuronium
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2016)
37
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2013)
40
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or older
  • Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h
  • Physical status ASA I - III

Exclusion Criteria:

  • Pregnancy
  • Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
  • Previous lung surgery
  • History of severe chronic obstructive pulmonary disease
  • Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
  • Mechanical ventilation within the last 30 days
  • Neuromuscular disease
  • Consented for another interventional study or refusal to participate in the present study
  • Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02025075
Other Study ID Numbers  ICMJE Merck-50706
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marcos Vidal Melo, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Marcos Vidal Melo, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP