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Intraoperative Neuromuscular Blockade and Postoperative Atelectasis

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ClinicalTrials.gov Identifier: NCT03503565
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Hyungseok Seo, Kyung Hee University Hospital at Gangdong

April 6, 2018
April 20, 2018
August 9, 2018
August 15, 2018
November 30, 2019   (Final data collection date for primary outcome measure)
Atelectasis area on Chest CT [ Time Frame: 1 day after the end of surgery ]
Atelectasis on Chest CT The lung area was delineated manually. To calculate atelectasis, a region of interest was laid out that encircled the dense part of the lung, excluding large vessels. For further analysis, the lung was divided into four categories: areas with densities ranging from -1000 to -900 Hounsfield units (HU) were classified as over-aerated, from -900 to -500 HU as normally aerated, from -500 to -100 HU as poorly aerated, and from -100 to +100 HU as non-aerated (atelectasis). The proportion of non-aerated lung tissue (-100 to +100 HU) was calculated by dividing the area of the region of interest with the whole lungs.
Same as current
Complete list of historical versions of study NCT03503565 on ClinicalTrials.gov Archive Site
  • Number of patients defined as acute respiratory distress syndrome [ Time Frame: up to 7 days after the end of surgery ]

    Acute respiratory distress syndrome can be defined as follows;

    Bilateral opacities not fully explained by effusions, lobar/lung collapse or nodules on chest radiograph or CT scan and Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic edema if no risk factor present and Partial pressure of pulmonary arterial oxygen / Oxygen friction < 300 mmHg with positive end-expiratory pressure or continuous positive airway pressure of 5 cmH2O.

  • Number of patients defined as pneumonia [ Time Frame: up to 7 days after the end of surgery ]

    Pneumonia can be defined as follows;

    Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):

    1. new or progressive and persistent infiltrates
    2. consolidation
    3. cavitation; at least one of the following

    1) fever (>38.0 C) with no other recognized cause 2) White blood cell count < 4000/ml or >12,000/ml 3) for adults >70 yr, altered mental status with no other recognized cause; and at least two of the following

    1. new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
    2. new onset or worsening cough, or dyspnea, or tachypnea
    3. crackles or bronchial breath sounds
    4. worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
  • Number of patients showing pleural effusion [ Time Frame: 1 day after the end of surgery ]
    Pleural effusion can be diagnosed on postoperative radiograph imaging.
  • Number of patients showing postoperative desaturation [ Time Frame: up to 1 day after surgery completed ]
    The number of patients showing desaturation (SpO2 <95%) in room air.
  • Number of patients requiring postoperative re-intubation [ Time Frame: up to 1 day after surgery completed ]
    The number of patients requiring re-intubation due to postoperative respiratory difficulty.
  • intraoperative lung compliance (ml/cmH2O) [ Time Frame: every 1 hour from the time of the tracheal intubation to the end of the skin closure. ]
    Intraoperative lung compliance (ml/cmH2O) can be calculated with peak inspiratory pressure or plateau pressure, positive end-expiratory pressure and tidal volume.
  • Patient demographic data [ Time Frame: on the day of admission ]
    Age in years, Gender, Weight in kilograms, Height in centimeters
Same as current
Not Provided
Not Provided
 
Intraoperative Neuromuscular Blockade and Postoperative Atelectasis
The Effect of Intraoperative Neuromuscular Blockade on Postoperative Atelectasis in Patients Undergoing Thoracic Surgery With One Lung Ventilation: Moderate vs. Deep Block
During one-lung ventilation in thoracic surgery, the intensity of neuromuscular blockade may change the compliance and resistance of ventilated lung, thereby affecting postoperative atelectasis. The present study investigated the effect of the intensity of intraoperative neuromuscular blockade on the postoperative atelectasis using chest computerized tomography in patients receiving thoracic surgery requiring one-lung ventilation.

Neuromuscular blocking agents can be used to secure a good surgical field, but it can also cause delayed extubation or postoperative pulmonary complications. Traditionally, rocuronium which is a commonly used non-depolarizing agent is usually reversed by cholinesterase inhibitors such as neostigmine or pyridostigmine. These drugs act by increasing the concentration of acetylcholine at the neuromuscular junction (a competing antagonist), not by direct antagonists. Consequently, there is a risk of pulmonary complications when cholinesterase inhibitor is not used appropriately. Use of sugammadex can reverse neuromuscular blockade (NMB) quickly, thereby being helpful for spontaneous deep breathing postoperatively. In a previous study, the moderate neuromuscular blockade was not guaranteed during surgery because intraoperative train-of-four (TOF) monitoring was not used and the outcome was focused on the correlation between reversal agent and the overall incidence of postoperative pulmonary complications. However, in the present study, TOF ratio or post-tetanic count (PTC) was repeatedly measured during surgery, thereby the intensity of intraoperative NMB being maintained. Moreover, lung compliance was repeatedly measured during surgery and the correlation between the intensity of intraoperative NMB and postoperative atelectasis which is evaluated by quantitative technique was also investigated.

Particularly in thoracic surgery, one lung ventilation is usually required for the surgical procedure. During one-lung ventilation, the compliance of ventilated lung is decreased and resistance can be increased, thereby the risk of atelectasis being increased. Furthermore, after thoracic surgery, although patients were encouraged to deep breathe, it is difficult to take a deep breath because of various factors. (i.e. pain, chest tube, long retracted time, postoperative interstitial edema, etc.) Therefore, postoperative atelectasis is much more important in patients undergoing thoracic surgery than other types of surgery.

For preventing postoperative atelectasis, the intraoperative intensity of neuromuscular blockade can be a crucial factor. Because deep neuromuscular blockade provides a good lung compliance during mechanical ventilation, peak inspiratory pressure can be decreased, thereby reducing the risk of ventilation-induced lung injury, particularly in one lung ventilation situation.However, there has been still lack of quantitative evidence that deep block is superior to moderate block in the thoracic surgery with one-lung ventilation

For assessment of postoperative atelectasis, plain chest radiography may be used. However, plain chest radiography can provide only a qualitative assessment of atelectasis. Computed tomography can assess the whole lung by its density (HU) and enables a quantitative assessment of postoperative atelectasis. Moreover, it can indicate the location of atelectasis more clearly than plain chest radiography, thus provide detailed information about postoperative lung state. To assess the effect of maintaining deep block and sugammadex reversal on the postoperative atelectasis, using chest CT can provide a much more quantitative and valuable information than conventional chest radiography.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients receiving open or thoracoscopic lobectomy, bi-lobectomy, or sleeve lobectomy.
  • Thoracic Surgery
  • One-lung Ventilation
Procedure: intraoperative neuromuscular blockade
The intensity of intraoperative neuromuscular blockade
  • Moderate block group
    maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery
    Intervention: Procedure: intraoperative neuromuscular blockade
  • Deep block group
    maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery
    Intervention: Procedure: intraoperative neuromuscular blockade

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
118
Same as current
December 30, 2019
November 30, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients receiving scheduled unilateral lung lobectomy.
  2. Patients age ≥19
  3. Patients of American Society of Anesthesiologist Physical Status 1 or 2

Exclusion Criteria:

  1. Patients receiving bilateral lung lobectomy
  2. Patients BMI > 35.0 or < 18.5 kg/m2
  3. Patients of contraindicated to epidural patients controlled analgesia
  4. Patients with neuromuscular disease (i.e. myasthenia gravis)
  5. Patients with major burn (more than 3rd degrees)
  6. Patients with compromised cardiopulmonary function.
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact: Hyungseok Seo, MD, PhD 82-10-2930-6885 ext 82-2-440-7809 seohyungseok@gmail.com
Not Provided
 
 
NCT03503565
2018-03-015
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Hyungseok Seo, Kyung Hee University Hospital at Gangdong
Kyung Hee University Hospital at Gangdong
Merck Sharp & Dohme Corp.
Principal Investigator: Hyungseok Seo, MD, PhD Kyung Hee University Hospital at Gangdong
Kyung Hee University Hospital at Gangdong
August 2018