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

Primary Purpose

Phrenic Nerve Paralysis

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

phrenic block

no phrenic block

About this trial

This is an interventional treatment trial for Phrenic Nerve Paralysis focused on measuring non-intubated general anaesthesia, video-assisted thoracoscopic surgery, phrenic block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shenzhen People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

phrenic block group

Control group

Arm Description

non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block

non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block

Outcomes

Primary Outcome Measures

the volume of anesthetic drugs

the volume of anesthetic drugs including sevoflurane,propofol and opioids during the operation

Secondary Outcome Measures

the time to get out of bed after surgery

note the time to get out of bed after surgery

the cost of hospitalization

note the the cost of hospitalization

Full Information

NCT ID

NCT03653494

First Posted

July 16, 2018

Last Updated

August 28, 2018

Sponsor

Shenzhen People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03653494

Brief Title

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

Official Title

Department of Anesthesiology in Shenzhen People's Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Phrenic Nerve Paralysis

Keywords

non-intubated general anaesthesia, video-assisted thoracoscopic surgery, phrenic block

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Volunteers and data collectors was masked

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

phrenic block group

Arm Type

Experimental

Arm Description

non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block

Intervention Type

Procedure

Intervention Name(s)

phrenic block

Intervention Description

phrenic block by 1% ropivacaine 5ml

Intervention Type

Procedure

Intervention Name(s)

no phrenic block

Intervention Description

no phrenic block

Primary Outcome Measure Information:

Title

the volume of anesthetic drugs

Description

the volume of anesthetic drugs including sevoflurane,propofol and opioids during the operation

Time Frame

the time of operation， an average of 4 hours

Secondary Outcome Measure Information:

Title

the time to get out of bed after surgery

Description

note the time to get out of bed after surgery

Time Frame

two days after surgery

Title

the cost of hospitalization

Description

note the the cost of hospitalization

Time Frame

the time of hospitalization， an average of 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dai Z Liang, Doctor

Organizational Affiliation

Shenzhen People's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shenzhen People's Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518020

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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