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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

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.

Condition or disease Intervention/treatment Phase
Intraoperative Complications Postoperative Complications Laparoscopy Surgical Complications From General Anesthesia Ventilator-Induced Lung Injury Drug: Rocuronium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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.
Study Start Date : January 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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

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).
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




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02025075


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Marcos Vidal Melo, MD, PhD Massachusetts General Hospital

Publications:
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Responsible Party: Marcos Vidal Melo, Associate Professor of Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02025075    
Other Study ID Numbers: Merck-50706
First Posted: December 31, 2013    Key Record Dates
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Keywords provided by Marcos Vidal Melo, Massachusetts General Hospital:
Tomography
Oximetry
Echocardiography
Additional relevant MeSH terms:
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Lung Injury
Ventilator-Induced Lung Injury
Postoperative Complications
Intraoperative Complications
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs