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AzTrials

Thoracoscopic SurgeryNCT05595096

Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery

A study testing General anesthesia with preservation of spontaneous breathing in people with Thoracoscopic Surgery, run by Zhenjiang First People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Thoracoscopic Surgery
What is being tested?
General anesthesia with preservation of spontaneous breathing
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
1 Feb 2021to 31 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated People's Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212002

Other trials in China

About this study

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:

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

Read the detailed 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

Being tested
General anesthesia with preservation of spontaneous breathing
Keywords
Spontaneous breathing anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General anesthesia with preservation of spontaneous breathingProcedure or surgery

    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

Study groups in NCT05595096
Study groupRoleWhat they receive
spontaneous breathing anesthesia non-intubation groupExperimentalIn this group all the patients with spontaneous breathing anesthesia
Receives: Procedure: General anesthesia with preservation of spontaneous breathing
general anesthesia with double-lumen endotracheal intubation groupNo interventionIn this group all the patients with tradition anesthesia with double-lumen endotracheal intubation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the hospitalized stay

    the hospitalized stay

    Measured: 1 year

Secondary outcomes (2)

  1. Visual analogue score (VAS) after operation;

    Visual analogue score (VAS) was compared between the two groups

    Measured: 1 year

  2. The postoperative complications

    postoperative nausea and vomiting(PONV), pulmonary infection, atelectasis, sore throat, hoarseness

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2022
  2. Study start1 Feb 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05595096
Sponsor's protocol ID
Y2021017
Status last verified
Oct 2022
First submitted
18 Oct 2022
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all collected IPD, all IPD that underlie results in a publication

Publications

  • 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.

    PubMed 28962712

  • 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.

    PubMed 31761286

  • 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.

    PubMed 30174869

  • 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.

    PubMed 32082924

  • 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.

    PubMed 28795911

  • 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.

    PubMed 24455174

  • 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.

    PubMed 30505496

  • 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.

    PubMed 26083767

  • 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.

    PubMed 9175983

  • 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.

    PubMed 28097305

  • 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.

    PubMed 31588634

  • 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.

    PubMed 24821259

  • 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.

    PubMed 32737760

  • 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.

    PubMed 31330457

  • 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.

    PubMed 27543524

Questions about this trial

What is this clinical trial studying?

A study testing General anesthesia with preservation of spontaneous breathing in people with Thoracoscopic Surgery, run by Zhenjiang First People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the hospitalized stay (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05595096, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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