Clinical trial NCT03503565: Intraoperative Neuromuscular Blockade and Postoperative Atelectasis
Official title: The Effect of Intraoperative Neuromuscular Blockade on Postoperative Atelectasis in Patients Undergoing Thoracic Surgery With One Lung Ventilation: Moderate vs. Deep Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
One-lung Ventilation
Keywords: one-lung ventilation
thoracic surgery
atelectasis
postoperative pulmonary complication
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-04-20
Enrollment: 118
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving open or thoracoscopic lobectomy, bi-lobectomy, or sleeve lobectomy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Atelectasis Area on Chest CT
timeFrame: 1 day after the end of surgery
Secondary outcomes:
measure: Number of Patients Defined as Acute Respiratory Distress Syndrome
timeFrame: up to 7 days after the end of surgery
measure: Number of Patients Defined as Pneumonia
timeFrame: up to 7 days after the end of surgery
measure: Number of Patients Showing Pleural Effusion
timeFrame: 1 day after the end of surgery
measure: Number of Patients Showing Postoperative Desaturation
timeFrame: up to 1 day after surgery completed
measure: Number of Patients Requiring Postoperative Re-intubation
timeFrame: up to 1 day after surgery completed
measure: Intraoperative Lung Compliance (ml/cmH2O)
timeFrame: every 1 hour from the time of the tracheal intubation to the end of the skin closure.
measure: Patient Demographic Data
timeFrame: on the day of admission
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Gangdong Hospital
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Hyungseok Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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