Intraoperative Neuromuscular Blockade and Postoperative Atelectasis

NCT ID: NCT03503565

Last Updated: 2021-08-20

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-11

Study Completion Date

2021-05-18

Brief Summary

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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

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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.

Conditions

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Thoracic Surgery One-lung Ventilation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

The intensity of intraoperative neuromuscular blockade

Interventions

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intraoperative neuromuscular blockade

The intensity of intraoperative neuromuscular blockade

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role lead

Responsible Party

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Hyungseok Seo

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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South Korea

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.

Reference Type BACKGROUND
PMID: 28794837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23077290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27496656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28256331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19809292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25058504 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2018-03-015

Identifier Type: -

Identifier Source: org_study_id

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