Intraoperative Neuromuscular Blockade and Postoperative Atelectasis
NCT ID: NCT03503565
Last Updated: 2021-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
118 participants
OBSERVATIONAL
2018-10-11
2021-05-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Moderate block group
maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery
intraoperative neuromuscular blockade
The intensity of 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
intraoperative neuromuscular blockade
The intensity of intraoperative neuromuscular blockade
Interventions
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intraoperative neuromuscular blockade
The intensity of intraoperative neuromuscular blockade
Eligibility Criteria
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Inclusion Criteria
2. Patients age ≥19
3. Patients of American Society of Anesthesiologist Physical Status 1 or 2
Exclusion Criteria
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.
19 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Kyung Hee University Hospital at Gangdong
OTHER
Responsible Party
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Hyungseok Seo
Clinical Associate Professor
Principal Investigators
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Hyungseok Seo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital at Gangdong
Locations
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Kyung Hee University Gangdong Hospital
Seoul, , South Korea
Countries
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References
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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.
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.
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.
Casanova J, Pineiro 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.
Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden 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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2018-03-015
Identifier Type: -
Identifier Source: org_study_id
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