the Clinicaltrail of the Effection Which of Phrenic Block... | NCT03653494

Studies
the Clinicaltrail of the Effection Which of Phrenic Block Using in Non-intubated Video-assisted Thoracoscopic Surgery

NCT03653494

Sponsor

Shenzhen People's Hospital

Status

Unknown status

Last Update Posted

Aug 31, 2018Actual

Enrollment

80Estimated

Phase

Early Phase 1

Conditions

Phrenic Nerve Paralysis

Interventions

phrenic block
no phrenic block

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Estimated

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Jul 16, 2018

First Submission Date that Met QC Criteria

Aug 28, 2018

First Posted Date

Aug 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2018

Last Update Posted Date

Aug 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Putting 80 patients divided into group S（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block） and group D（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block）randomly,compare the volume of anesthetic and the number of increasing anesthetic during operation were compared between the two groups.If the date of group S greater than group D，it shows that the effect of anesthetic effect of group D is better than group S.

Detailed Description

Put 80 patients divided into group S（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block） and group D（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block）randomly.
Compare the volume of anesthetic drugs between the two groups.
If the date of group S greater than group D，it shows that the effect of anesthetic effect of group D is better than group S.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
phrenic block group	Experimental	non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block	Procedure: phrenic block
Control group	Active Comparator	non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block	Procedure: no phrenic block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
phrenic block	Procedure	phrenic block by 1% ropivacaine 5ml	phrenic block group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the volume of anesthetic drugs	the volume of anesthetic drugs including sevoflurane,propofol and opioids during the operation	the time of operation， an average of 4 hours

Secondary Outcomes

Measure	Description	Time Frame
the time to get out of bed after surgery	note the time to get out of bed after surgery	two days after surgery
the cost of hospitalization	note the the cost of hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient agreed to perform non-intubated video-assisted thoracoscopic surgery, and informed the possibility of intraoperative tracheal intubation or thoracotomy.
No conventional anesthesia contraindication, no history of thoracic surgery, good cardiopulmonary function.
There is no severe adhesion and calcification in the thoracic cavity, and no artificial pneumothorax is affected.
the patient has no serious anxiety or depression.
Small surgical trauma, simple steps, short time.

Exclusion Criteria:

Mallampati≥3.
BMI≥26 kg/m2.
Hemodynamic instability.
INR≥1.5.
Respiratory infection, persistent cough or airway mucus hypersecretion, high risk of reflux.
nervous system disease,such as seizure or brain edema.
Extensive pleural adhesions or once chest surgery.
PaO2<60mmHg or PaCO2>50 mmHg.
Central hypopnea syndrome.
Lung isolation should be used to protect the healthy side of the lung.
Complicated operation, large trauma, long time, lack of experience or poor cooperation in the surgical team.
Contraindications to local anesthetic.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dai Z Liang, Doctor	Shenzhen People's Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Shenzhen People's Hospital		Shenzhen	Guangdong	518020	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Apr 10, 2020
Reset	Apr 24, 2020

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 10, 2020			Apr 24, 2020

Intervention Model Description

Put 80 patients divided into group S（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block） and group D（non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block）randomly.
Compare the volume of anesthetic drugs between the two groups.
If the date of group S greater than group D，it shows that the effect of anesthetic effect of group D is better than group S.