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

NCT ID: NCT03653494

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2018-12-31

Brief Summary

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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

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1. 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.
2. Compare the volume of anesthetic drugs between the two groups.
3. 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.

Conditions

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Phrenic Nerve Paralysis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. 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.
2. Compare the volume of anesthetic drugs between the two groups.
3. 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Volunteers and data collectors was masked

Study Groups

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phrenic block group

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

Group Type EXPERIMENTAL

phrenic block

Intervention Type PROCEDURE

phrenic block by 1% ropivacaine 5ml

Control group

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

Group Type ACTIVE_COMPARATOR

no phrenic block

Intervention Type PROCEDURE

no phrenic block

Interventions

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phrenic block

phrenic block by 1% ropivacaine 5ml

Intervention Type PROCEDURE

no phrenic block

no phrenic block

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dai Z Liang, Doctor

Role: STUDY_CHAIR

Shenzhen People's Hospital

Locations

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Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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daizhongliang-02

Identifier Type: -

Identifier Source: org_study_id