Intraoperative Neuromuscular Blockade and Postoperative Atelectasis

Thoracic Surgery Clinical Trial

Official title:

The Effect of Intraoperative Neuromuscular Blockade on Postoperative Atelectasis in Patients Undergoing Thoracic Surgery With One Lung Ventilation: Moderate vs. Deep Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503565
• Other study ID #: 2018-03-015
• Status: Completed
• Start date: October 11, 2018
• Est. completion date: May 18, 2021

Study information

• Verified date: August 2021
• Source: Kyung Hee University Hospital at Gangdong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 18, 2021
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• One-lung Ventilation
• Pulmonary Atelectasis
• Thoracic Surgery

Intervention

Procedure:
• intraoperative neuromuscular blockade
The intensity of intraoperative neuromuscular blockade

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Gangdong Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Bulka CM, Terekhov MA, Martin BJ, Dmochowski RR, Hayes RM, Ehrenfeld JM. Nondepolarizing Neuromuscular Blocking Agents, Reversal, and Risk of Postoperative Pneumonia. Anesthesiology. 2016 Oct;125(4):647-55. doi: 10.1097/ALN.0000000000001279. — View Citation

Casanova J, Piñeiro P, De La Gala F, Olmedilla L, Cruz P, Duque P, Garutti I. [Deep versus moderate neuromuscular block during one-lung ventilation in lung resection surgery]. Rev Bras Anestesiol. 2017 May - Jun;67(3):288-293. doi: 10.1016/j.bjan.2017.02.005. Epub 2017 Feb 27. Portuguese. — View Citation

Cho HC, Lee JH, Lee SC, Park SY, Rim JC, Choi SR. Use of sugammadex in lung cancer patients undergoing video-assisted thoracoscopic lobectomy. Korean J Anesthesiol. 2017 Aug;70(4):420-425. doi: 10.4097/kjae.2017.70.4.420. Epub 2017 Apr 21. — View Citation

Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329. — View Citation

Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118. — View Citation

Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Fredén F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atelectasis Area on Chest CT	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.	1 day after the end of surgery
Secondary	Number of Patients Defined as Acute Respiratory Distress Syndrome	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.	up to 7 days after the end of surgery
Secondary	Number of Patients Defined as Pneumonia	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): new or progressive and persistent infiltrates; consolidation; 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; new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements; new onset or worsening cough, or dyspnea, or tachypnea; crackles or bronchial breath sounds; worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).	up to 7 days after the end of surgery
Secondary	Number of Patients Showing Pleural Effusion	Pleural effusion can be diagnosed on postoperative radiograph imaging.	1 day after the end of surgery
Secondary	Number of Patients Showing Postoperative Desaturation	The number of patients showing desaturation (SpO2 <95%) in room air.	up to 1 day after surgery completed
Secondary	Number of Patients Requiring Postoperative Re-intubation	The number of patients requiring re-intubation due to postoperative respiratory difficulty.	up to 1 day after surgery completed
Secondary	Intraoperative Lung Compliance (ml/cmH2O)	Intraoperative lung compliance (ml/cmH2O) can be calculated with peak inspiratory pressure or plateau pressure, positive end-expiratory pressure and tidal volume.	every 1 hour from the time of the tracheal intubation to the end of the skin closure.
Secondary	Patient Demographic Data	Age in years, Gender, Weight in kilograms, Height in centimeters	on the day of admission