Back to resultsPreservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery
Primary Purpose
Thoracoscopic Surgery
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
General anesthesia with preservation of spontaneous breathing
Sponsored by
About this trial
This is an interventional treatment trial for Thoracoscopic Surgery focused on measuring Spontaneous breathing anesthesia
Eligibility Criteria
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
Sites / Locations
- Affiliated People's Hospital of Jiangsu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
spontaneous breathing anesthesia non-intubation group
general anesthesia with double-lumen endotracheal intubation group
Arm Description
In this group all the patients with spontaneous breathing anesthesia
In this group all the patients with tradition anesthesia with double-lumen endotracheal intubation
Outcomes
Primary Outcome Measures
the hospitalized stay
the hospitalized stay
Secondary Outcome Measures
Visual analogue score (VAS) after operation;
Visual analogue score (VAS) was compared between the two groups
The postoperative complications
postoperative nausea and vomiting(PONV), pulmonary infection, atelectasis, sore throat, hoarseness
Full Information
NCT ID
NCT05595096
First Posted
October 18, 2022
Last Updated
October 25, 2022
Sponsor
Zhenjiang First People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05595096
Brief Title
Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery
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:
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhenjiang First People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracoscopic Surgery
Keywords
Spontaneous breathing anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spontaneous breathing anesthesia non-intubation group
Arm Type
Experimental
Arm Description
In this group all the patients with spontaneous breathing anesthesia
Arm Title
general anesthesia with double-lumen endotracheal intubation group
Arm Type
No Intervention
Arm Description
In this group all the patients with tradition anesthesia with double-lumen endotracheal intubation
Intervention Type
Procedure
Intervention Name(s)
General anesthesia with preservation of spontaneous breathing
Intervention Description
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
Primary Outcome Measure Information:
Title
the hospitalized stay
Description
the hospitalized stay
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual analogue score (VAS) after operation;
Description
Visual analogue score (VAS) was compared between the two groups
Time Frame
1 year
Title
The postoperative complications
Description
postoperative nausea and vomiting(PONV), pulmonary infection, atelectasis, sore throat, hoarseness
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sun caixia, doctor
Organizational Affiliation
Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated People's Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212002
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
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Learn more about this trial
Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery
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