Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery

NCT ID: NCT05595096

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-01-31

Brief Summary

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

Detailed Description

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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

Conditions

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Thoracoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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spontaneous breathing anesthesia non-intubation group

In this group all the patients with spontaneous breathing anesthesia

Group Type EXPERIMENTAL

General anesthesia with preservation of spontaneous breathing

Intervention Type 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

general anesthesia with double-lumen endotracheal intubation group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhenjiang First People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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sun caixia, doctor

Role: STUDY_DIRECTOR

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

Locations

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Affiliated People's Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 28962712 (View on PubMed)

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.

Reference Type RESULT
PMID: 31761286 (View on PubMed)

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.

Reference Type RESULT
PMID: 30174869 (View on PubMed)

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.

Reference Type RESULT
PMID: 32082924 (View on PubMed)

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.

Reference Type RESULT
PMID: 28795911 (View on PubMed)

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.

Reference Type RESULT
PMID: 24455174 (View on PubMed)

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.

Reference Type RESULT
PMID: 30505496 (View on PubMed)

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.

Reference Type RESULT
PMID: 26083767 (View on PubMed)

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.

Reference Type RESULT
PMID: 9175983 (View on PubMed)

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.

Reference Type RESULT
PMID: 28097305 (View on PubMed)

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.

Reference Type RESULT
PMID: 31588634 (View on PubMed)

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.

Reference Type RESULT
PMID: 24821259 (View on PubMed)

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.

Reference Type RESULT
PMID: 32737760 (View on PubMed)

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.

Reference Type RESULT
PMID: 31330457 (View on PubMed)

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.

Reference Type RESULT
PMID: 27543524 (View on PubMed)

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.

Reference Type RESULT
PMID: 20947592 (View on PubMed)

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.

Reference Type RESULT
PMID: 34938770 (View on PubMed)

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.

Reference Type RESULT
PMID: 34818467 (View on PubMed)

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.

Reference Type RESULT
PMID: 35071477 (View on PubMed)

Other Identifiers

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Y2021017

Identifier Type: -

Identifier Source: org_study_id

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