Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery

Sponsor

Zhenjiang First People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05595096

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Thoracoscopic Surgery	Procedure: General anesthesia with preservation of spontaneous breathing	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Primary Purpose:

Treatment

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:

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the hospitalized stay [1 year]
the hospitalized stay

Secondary Outcome Measures

Visual analogue score (VAS) after operation; [1 year]
Visual analogue score (VAS) was compared between the two groups
The postoperative complications [1 year]
postoperative nausea and vomiting(PONV), pulmonary infection, atelectasis, sore throat, hoarseness

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated People's Hospital of Jiangsu University	Zhenjiang	Jiangsu	China	212002

Sponsors and Collaborators

Zhenjiang First People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Zhenjiang First People's Hospital

ClinicalTrials.gov Identifier:

NCT05595096

Other Study ID Numbers:

Y2021017

First Posted:

Oct 26, 2022

Last Update Posted:

Oct 26, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhenjiang First People's Hospital

Spontaneous breathing anesthesia

Additional relevant MeSH terms:

Respiratory Aspiration

Anesthetics

Study Results

No Results Posted as of Oct 26, 2022