Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery

Thoracoscopic Surgery Clinical Trial

Official title:

Comparison of Thoracic Paravertebral Nerve Block Combined Laryngeal Mask Airway With Preservation of Spontaneous Breathing Versus General Anesthesia Using Double-lumen Endobronchial Intubation in Patients Undergoing Thoracoscopic Surgery:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05595096
• Other study ID #: Y2021017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: October 2022
• Source: Zhenjiang First People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of this study is to evaluate the advantages of the non-intubation compared with intubation anesthesia on enhanced recovery after thoracoscopic surgery

Description:

All patients will be screened to determine eligibility for study entry, and the patients who meet the eligibility requirements will be informed about the study and potential risks. After giving written informed consent, The patients were randomly divided into non-intubation group and intubation group

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• age 18-69 years old

• Body mass index (BMI) was 18-24 kg / m2

• American Society of Anesthesiologists' physical classification class I-II

• The preoperative pulmonary function was normal

Exclusion Criteria:

• Severe cardiopulmonary disease

• Severe nervous system diseases

• Severe blood system diseases

• Severe liver and kidney dysfunction

• Conversion to thoracotomy

Related Conditions & MeSH terms

• Respiratory Aspiration
• Thoracoscopic Surgery

Intervention

Procedure:
• General anesthesia with preservation of spontaneous breathing
non-intubation group, thoracic paravertebral nerve block was performed before anesthesia induction,when the BIS value drops to between 40 and 60, laryngeal mask airway(LMA) is placed,and observation of breathing

Locations

Country	Name	City	State
China	Affiliated People's Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhenjiang First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (19)

AlGhamdi ZM, Lynhiavu L, Moon YK, Moon MH, Ahn S, Kim Y, Sung SW. Comparison of non-intubated versus intubated video-assisted thoracoscopic lobectomy for lung cancer. J Thorac Dis. 2018 Jul;10(7):4236-4243. doi: 10.21037/jtd.2018.06.163. — View Citation

Cai LS, Hou B, Jin H, Bo Y, Chen XL, Dai J, Yang T, Lan BS, Ye J, Peng H, Peng J. Clinical evaluation of the rapid recovery of patients who underwent video-assisted thoracoscopic lung surgery under non-intubated anesthesia. Ann Transl Med. 2021 Dec;9(24): — View Citation

Chen N, Qiao Q, Chen R, Xu Q, Zhang Y, Tian Y. The effect of ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block on postoperative analgesia in thoracoscopic surgery: A randomize — View Citation

El-Boghdadly K, Madjdpour C, Chin KJ. Thoracic paravertebral blocks in abdominal surgery - a systematic review of randomized controlled trials. Br J Anaesth. 2016 Sep;117(3):297-308. doi: 10.1093/bja/aew269. Review. — View Citation

Gonzalez M, Abdelnour-Berchtold E, Perentes JY, Doucet V, Zellweger M, Marcucci C, Ris HB, Krueger T, Gronchi F. An enhanced recovery after surgery program for video-assisted thoracoscopic surgery anatomical lung resections is cost-effective. J Thorac Dis — View Citation

Guo Z, Shao W, Yin W, Chen H, Zhang X, Dong Q, Liang L, Wang W, Peng G, He J. Analysis of feasibility and safety of complete video-assisted thoracoscopic resection of anatomic pulmonary segments under non-intubated anesthesia. J Thorac Dis. 2014 Jan;6(1): — View Citation

Huang QW, Li JB, Huang Y, Zhang WQ, Lu ZW. A Comparison of Analgesia After a Thoracoscopic Lung Cancer Operation with a Sustained Epidural Block and a Sustained Paravertebral Block: A Randomized Controlled Study. Adv Ther. 2020 Sep;37(9):4000-4014. doi: 1 — View Citation

Hung WT, Cheng YJ, Chen JS. Video-Assisted Thoracoscopic Surgery Lobectomy for Lung Cancer in Nonintubated Anesthesia. Thorac Surg Clin. 2020 Feb;30(1):73-82. doi: 10.1016/j.thorsurg.2019.09.002. Review. — View Citation

Janík M, Juhos P, Lucenic M, Tarabová K. Non-intubated Thoracoscopic Surgery-Pros and Cons. Front Surg. 2021 Dec 6;8:801718. doi: 10.3389/fsurg.2021.801718. eCollection 2021. Review. — View Citation

Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. Review. — View Citation

Kocatürk C, Kutluk AC, Usluer O, Onat S, Çinar HU, Yanik F, Cesur E, Ülkü R, Karamustafaoglu A, Çelik B, Demirhan R, Kalafat CE, Özpolat B. Comparison of awake and intubated video-assisted thoracoscopic surgery in the diagnosis of pleural diseases: A pros — View Citation

Krediet AC, Moayeri N, van Geffen GJ, Bruhn J, Renes S, Bigeleisen PE, Groen GJ. Different Approaches to Ultrasound-guided Thoracic Paravertebral Block: An Illustrated Review. Anesthesiology. 2015 Aug;123(2):459-74. doi: 10.1097/ALN.0000000000000747. Revi — View Citation

Liu J, Cui F, Li S, Chen H, Shao W, Liang L, Yin W, Lin Y, He J. Nonintubated video-assisted thoracoscopic surgery under epidural anesthesia compared with conventional anesthetic option: a randomized control study. Surg Innov. 2015 Apr;22(2):123-30. doi: — View Citation

Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952. Review. — View Citation

Qi L, Chen K, Luo B, Mao G, Pan L, Huang H, Li J, Chen S. Clinical application of preserving spontaneous breathing non-intubation anesthesia in thoracoscopic surgery for lung cancer under ERAS concept. Asia Pac J Clin Oncol. 2022 Oct;18(5):e329-e337. doi: — View Citation

Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14. Re — View Citation

Senturk JC, Kristo G, Gold J, Bleday R, Whang E. The Development of Enhanced Recovery After Surgery Across Surgical Specialties. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):863-870. doi: 10.1089/lap.2017.0317. Epub 2017 Aug 10. Review. — View Citation

Shen C, Che G. Tubeless minimally invasive treatment: taking a new step in enhanced recovery after surgery (ERAS). Thorac Cancer. 2019 Nov;10(11):2067-2070. doi: 10.1111/1759-7714.13206. Epub 2019 Oct 7. — View Citation

Zheng H, Hu XF, Jiang GN, Ding JA, Zhu YM. Nonintubated-Awake Anesthesia for Uniportal Video-Assisted Thoracic Surgery Procedures. Thorac Surg Clin. 2017 Nov;27(4):399-406. doi: 10.1016/j.thorsurg.2017.06.008. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the hospitalized stay	the hospitalized stay	1 year
Secondary	Visual analogue score (VAS) after operation;	Visual analogue score (VAS) was compared between the two groups	1 year
Secondary	The postoperative complications	postoperative nausea and vomiting(PONV), pulmonary infection, atelectasis, sore throat, hoarseness	1 year