Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery

NCT05595096 | Completed

• 1 other identifier: Y2021017
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Thoracoscopic Surgery

Keywords

Spontaneous breathing anesthesia

Outcome Measures

Primary Outcomes (1)

• the hospitalized stay

  the hospitalized stay

  1 year

Secondary Outcomes (2)

• Visual analogue score (VAS) after operation;

  1 year

• The postoperative complications

  1 year

Study Arms (2)

spontaneous breathing anesthesia non-intubation group

EXPERIMENTAL

In this group all the patients with spontaneous breathing anesthesia

Procedure: General anesthesia with preservation of spontaneous breathing

general anesthesia with double-lumen endotracheal intubation group

NO INTERVENTION

In this group all the patients with tradition anesthesia with double-lumen endotracheal intubation

Interventions

General anesthesia with preservation of spontaneous breathing PROCEDURE

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

spontaneous breathing anesthesia non-intubation group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe cardiopulmonary disease
• Severe nervous system diseases
• Severe blood system diseases
• Severe liver and kidney dysfunction
• Conversion to thoracotomy

Sponsors & Collaborators

• Zhenjiang First People's Hospital: lead

Study Sites (1)

Affiliated People's Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212002, China

Location

Related Publications (19)

• 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.

  PMID: 28962712 BACKGROUND

• 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.

  PMID: 31761286 RESULT

• 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.

  PMID: 30174869 RESULT

• Kocaturk C, Kutluk AC, Usluer O, Onat S, Cinar HU, Yanik F, Cesur E, Ulku R, Karamustafaoglu A, Celik B, Demirhan R, Kalafat CE, Ozpolat B. Comparison of awake and intubated video-assisted thoracoscopic surgery in the diagnosis of pleural diseases: A prospective multicenter randomized trial. Turk Gogus Kalp Damar Cerrahisi Derg. 2019 Oct 23;27(4):550-556. doi: 10.5606/tgkdc.dergisi.2019.18214. eCollection 2019 Oct.

  PMID: 32082924 RESULT

• 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.

  PMID: 28795911 RESULT

• 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):37-44. doi: 10.3978/j.issn.2072-1439.2014.01.06.

  PMID: 24455174 RESULT

• 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. 2018 Oct;10(10):5879-5888. doi: 10.21037/jtd.2018.09.100.

  PMID: 30505496 RESULT

• 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.

  PMID: 26083767 RESULT

• Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

  PMID: 9175983 RESULT

• 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.

  PMID: 28097305 RESULT

• 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. No abstract available.

  PMID: 31588634 RESULT

• 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: 10.1177/1553350614531662. Epub 2014 May 12.

  PMID: 24821259 RESULT

• 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: 10.1007/s12325-020-01446-3. Epub 2020 Jul 31.

  PMID: 32737760 RESULT

• 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 randomized, double-blinded, clinical trial. J Clin Anesth. 2020 Feb;59:106-111. doi: 10.1016/j.jclinane.2019.07.002. Epub 2019 Jul 19.

  PMID: 31330457 RESULT

• 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.

  PMID: 27543524 RESULT

• 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.

  PMID: 20947592 RESULT

• Janik M, Juhos P, Lucenic M, Tarabova K. Non-intubated Thoracoscopic Surgery-Pros and Cons. Front Surg. 2021 Dec 6;8:801718. doi: 10.3389/fsurg.2021.801718. eCollection 2021.

  PMID: 34938770 RESULT

• 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: 10.1111/ajco.13726. Epub 2021 Nov 24.

  PMID: 34818467 RESULT

• 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):1783. doi: 10.21037/atm-21-6434.

  PMID: 35071477 RESULT

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• sun caixia, doctor

  Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-intubation group: thoracic paravertebral nerve block was performed before anesthesia induction,after anesthesia induction laryngeal mask airway(LMA) is placed. intubation group:were given routine induction with double-lumen endotracheal intubation.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 26, 2022
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data are available after publication and up to one year after publication
• Access Criteria: Send an email to zhengyf.163@163.com

Locations

CN (1)