Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery

October 25, 2022 updated by: Zhenjiang First People's Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Zhenjiang, Jiangsu, China, 212002
        • Affiliated People's Hospital of Jiangsu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: spontaneous breathing anesthesia non-intubation group
In this group all the patients with spontaneous breathing anesthesia
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
No Intervention: general anesthesia with double-lumen endotracheal intubation group
In this group all the patients with tradition anesthesia with double-lumen endotracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the hospitalized stay
Time Frame: 1 year
the hospitalized stay
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue score (VAS) after operation;
Time Frame: 1 year
Visual analogue score (VAS) was compared between the two groups
1 year
The postoperative complications
Time Frame: 1 year
postoperative nausea and vomiting(PONV), pulmonary infection, atelectasis, sore throat, hoarseness
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhenjiang First People's Hospital

Investigators

  • Study Director: sun caixia, doctor, Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y2021017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

Data are available after publication and up to one year after publication

IPD Sharing Access Criteria

Send an email to zhengyf.163@163.com

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thoracoscopic Surgery

Clinical Trials on General anesthesia with preservation of spontaneous breathing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe