Perioperative nebulization of ipratropium bromide in patients with chronic obstructive pulmonary disease under thoracic surgery: A randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LIU Lunxu ¹ , WANG Tianyou ² ,  ZHANG Xun ³ , FU Xiangning ⁴ , ZHAO Heng ⁵ , LI Zhijun ⁶ , YAN Yusheng ⁷ , FAN Feng ⁸

1. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
2. Department of Thoracic Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, P. R. China;
3. Department of Thoracic Surgery, Tianjin Chest Hospital, Tianjin, 300051, P. R. China;
4. Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, 430032, P. R. China;
5. Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 200030, P. R. China;
6. Department of Thoracic Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310036, P. R. China;
7. Department of Thoracic Surgery, Zhujiang Hospital of Southern Medical University, Guangzhou, 510280, P. R. China;
8. Department of Medicine, Boehringer Ingelheim (China) Investment Co. Ltd., Shanghai, 200040, P. R. China;

Corresponding author：

ZHANG Xun, Email: xunzhang123@sina.cn

Keywords：

Chronic obstructive pulmonary disease (COPD); perioperative period; ipratropium bromide; preoperative lung function; postoperative pulmonary complications

DOI：

10.7507/1007-4848.202109019

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the effect of perioperative nebulization of ipratropium bromide on preoperative pulmonary function and incidence of postoperative pulmonary complications as well as safety in chronic obstructive pulmonary disease (COPD) patients who underwent lung resection in thoracic surgery. Methods During November 18, 2013 to August 12, 2015, 192 COPD patients with a necessity of selective surgical procedures of lobectomy or right bilobectomy or segmentectomy under general anaesthesia in 10 centers were 1 : 1 randomized to an ipratropium bromide group (96 patients) and a placebo group (96 patients), to compare the effect on preoperative pulmonary function and incidence of postoperative pulmonary complications. The average age of treated patients was 62.90±6.50 years, with 168 male patients and 22 female patients. Results The demographic and baseline characteristics were well-balanced between the two groups. The adjusted mean increase of forced expiratory volume in one second (FEV₁) in the ipratropium bromide group was significantly higher than that in the placebo group (169.90±29.07 mL vs. 15.00±29.35 mL, P<0.05). The perioperative use of ipratropium bromide significantly decreased incidence of postoperative pneumonia (2.6% vs. 14.1%, P<0.05). There was no ipratropium bromide related adverse event (AE) observed in this trial. Conclusion This trial indicates that perioperative nebulization of ipratropium bromide significantly improves preoperative lung function and reduces postoperative pneumonia in COPD patients undergoing lung resection in thoracic surgery, and has good safety profile.

Citation： LIU Lunxu, WANG Tianyou, ZHANG Xun, FU Xiangning, ZHAO Heng, LI Zhijun, YAN Yusheng, FAN Feng. Perioperative nebulization of ipratropium bromide in patients with chronic obstructive pulmonary disease under thoracic surgery: A randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(4): 417-423. doi: 10.7507/1007-4848.202109019 Copy

1.	Abbott TEF, Fowler AJ, Pelosi P, et al. A systematic review and consensus definitions for standardised end-points in perioperative medicine: Pulmonary complications. Br J Anaesth, 2018, 120(5): 1066-1079.
2.	Fernandez-Bustamante A, Frendl G, Sprung J, et al. Postoperative pulmonary complications, early mortality, and hospital stay following noncardiothoracic surgery: A multicenter study by the perioperative research network investigators. JAMA Surg, 2017, 152(2): 157-166.
3.	Yang CK, Teng A, Lee DY, et al. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res, 2015, 198(2): 441-449.
4.	Gallart L, Canet J. Post-operative pulmonary complications: Understanding definitions and risk assessment. Best Pract Res Clin Anaesthesiol, 2015, 29(3): 315-330.
5.	Gupta H, Ramanan B, Gupta PK, et al. Impact of COPD on postoperative outcomes: Results from a national database. Chest, 2013, 143(6): 1599-1606.
6.	Wang C, Xu J, Yang L, et al; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health study): A national cross-sectional study. Lancet, 2018, 391(10131): 1706-1717.
7.	Shin B, Lee H, Kang D, et al. Airflow limitation severity and post-operative pulmonary complications following extra-pulmonary surgery in COPD patients. Respirology, 2017, 22(5): 935-941.
8.	Takegahara K, Usuda J, Inoue T, et al. Preoperative management using inhalation therapy for pulmonary complications in lung cancer patients with chronic obstructive pulmonary disease. Gen Thorac Cardiovasc Surg, 2017, 65(7): 388-391.
9.	中国医学装备协会呼吸病学专委会吸入治疗与呼吸康复学组, 中国慢性阻塞性肺疾病联盟. 稳定期慢性气道疾病吸入装置规范应用中国专家共识. 中华结核和呼吸杂志, 2019, 42(4): 241-253.
10.	陈宝, 范峰, 傅柏涵, 等. 异丙托溴铵雾化治疗用于围手术期慢性阻塞性肺疾病中国患者Ⅳ期临床试验. 中华胸心血管外科杂志, 2017, 33(3): 175-178.
11.	Tashkin DP, Ashutosh K, Bleecker ER, et al. Comparison of the anticholinergic bronchodilator ipratropium bromide with metaproterenol in chronic obstructive pulmonary disease. A 90-day multi-center study. Am J Med, 1986, 81(5A): 81-90.
12.	Shander A, Fleisher LA, Barie PS, et al. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med, 2011, 39(9): 2163-2172.
13.	2021 Global Initiative for Chronic Obstructive Lung Disease. URL: https://goldcopd.org/. Accessed on 2021-09-16.
14.	The COMBIVENT Inhalation Solution Study Group. Routine nebulized ipratropium and albuterol together are better than either alone in COPD. Chest, 1997, 112(6): 1514-1521.
15.	中华医学会临床药学分会《雾化吸入疗法合理用药专家共识》编写组. 雾化吸入疗法合理用药专家共识(2019年版). 医药导报, 2019, 38(2): 135-146.

1. Abbott TEF, Fowler AJ, Pelosi P, et al. A systematic review and consensus definitions for standardised end-points in perioperative medicine: Pulmonary complications. Br J Anaesth, 2018, 120(5): 1066-1079.
2. Fernandez-Bustamante A, Frendl G, Sprung J, et al. Postoperative pulmonary complications, early mortality, and hospital stay following noncardiothoracic surgery: A multicenter study by the perioperative research network investigators. JAMA Surg, 2017, 152(2): 157-166.
3. Yang CK, Teng A, Lee DY, et al. Pulmonary complications after major abdominal surgery: National Surgical Quality Improvement Program analysis. J Surg Res, 2015, 198(2): 441-449.
4. Gallart L, Canet J. Post-operative pulmonary complications: Understanding definitions and risk assessment. Best Pract Res Clin Anaesthesiol, 2015, 29(3): 315-330.
5. Gupta H, Ramanan B, Gupta PK, et al. Impact of COPD on postoperative outcomes: Results from a national database. Chest, 2013, 143(6): 1599-1606.
6. Wang C, Xu J, Yang L, et al; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health study): A national cross-sectional study. Lancet, 2018, 391(10131): 1706-1717.
7. Shin B, Lee H, Kang D, et al. Airflow limitation severity and post-operative pulmonary complications following extra-pulmonary surgery in COPD patients. Respirology, 2017, 22(5): 935-941.
8. Takegahara K, Usuda J, Inoue T, et al. Preoperative management using inhalation therapy for pulmonary complications in lung cancer patients with chronic obstructive pulmonary disease. Gen Thorac Cardiovasc Surg, 2017, 65(7): 388-391.
9. 中国医学装备协会呼吸病学专委会吸入治疗与呼吸康复学组, 中国慢性阻塞性肺疾病联盟. 稳定期慢性气道疾病吸入装置规范应用中国专家共识. 中华结核和呼吸杂志, 2019, 42(4): 241-253.
10. 陈宝, 范峰, 傅柏涵, 等. 异丙托溴铵雾化治疗用于围手术期慢性阻塞性肺疾病中国患者Ⅳ期临床试验. 中华胸心血管外科杂志, 2017, 33(3): 175-178.
11. Tashkin DP, Ashutosh K, Bleecker ER, et al. Comparison of the anticholinergic bronchodilator ipratropium bromide with metaproterenol in chronic obstructive pulmonary disease. A 90-day multi-center study. Am J Med, 1986, 81(5A): 81-90.
12. Shander A, Fleisher LA, Barie PS, et al. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med, 2011, 39(9): 2163-2172.
13. 2021 Global Initiative for Chronic Obstructive Lung Disease. URL: https://goldcopd.org/. Accessed on 2021-09-16.
14. The COMBIVENT Inhalation Solution Study Group. Routine nebulized ipratropium and albuterol together are better than either alone in COPD. Chest, 1997, 112(6): 1514-1521.
15. 中华医学会临床药学分会《雾化吸入疗法合理用药专家共识》编写组. 雾化吸入疗法合理用药专家共识(2019年版). 医药导报, 2019, 38(2): 135-146.

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Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Perioperative nebulization of ipratropium bromide in patients with chronic obstructive pulmonary disease under thoracic surgery: A randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial

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