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
NCT number | NCT03503565 |
Other study ID # | 2018-03-015 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 11, 2018 |
Est. completion date | May 18, 2021 |
Verified date | August 2021 |
Source | Kyung Hee University Hospital at Gangdong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee University Gangdong Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyung Hee University Hospital at Gangdong | Merck Sharp & Dohme Corp. |
Korea, Republic of,
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
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 |
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