Intraoperative Neuromuscular Blockade and Postoperative Atelectasis

NCT03503565 | Completed Results

• 1 other identifier: 2018-03-015
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; One-lung Ventilation

Keywords

one-lung ventilation; thoracic surgery; atelectasis; postoperative pulmonary complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Patients Defined as Acute Respiratory Distress Syndrome

  up to 7 days after the end of surgery

• Number of Patients Defined as Pneumonia

  up to 7 days after the end of surgery

• Number of Patients Showing Pleural Effusion

  1 day after the end of surgery

• Number of Patients Showing Postoperative Desaturation

  up to 1 day after surgery completed

• Number of Patients Requiring Postoperative Re-intubation

  up to 1 day after surgery completed

Study Arms (2)

Moderate block group

maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery

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

Procedure: intraoperative neuromuscular blockade

Interventions

intraoperative neuromuscular blockade PROCEDURE

The intensity of intraoperative neuromuscular blockade

Deep block group; Moderate block group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving open or thoracoscopic lobectomy, bi-lobectomy, or sleeve lobectomy.

You may qualify if:

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

You may not qualify if:

• Patients receiving bilateral lung lobectomy
• Patients BMI \> 35.0 or \< 18.5 kg/m2
• Patients of contraindicated to epidural patients controlled analgesia
• Patients with neuromuscular disease (i.e. myasthenia gravis)
• Patients with major burn (more than 3rd degrees)
• Patients with compromised cardiopulmonary function.

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Kyung Hee University Gangdong Hospital

Seoul, 05278, South Korea

Location

Related Publications (6)

• 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.

  PMID: 28794837 BACKGROUND

• 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.

  PMID: 23077290 BACKGROUND

• 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.

  PMID: 27496656 BACKGROUND

• 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.

  PMID: 28256331 BACKGROUND

• 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.

  PMID: 19809292 BACKGROUND

• 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.

  PMID: 25058504 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Hyungseok Seo
• Organization: KYUNG HEE UNIVERSITY HOSPITAL AT GANGDONG

seohyungseok@gmail.com

+821029306885

Study Officials

• Hyungseok Seo, MD, PhD

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 20, 2018
• Study Start: October 11, 2018
• Primary Completion: May 14, 2020
• Study Completion: May 18, 2021
• Last Updated: August 20, 2021
• Results First Posted: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)