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

Basic Information

• 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

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

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

Phrenic Nerve Paralysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

phrenic block

phrenic block by 1% ropivacaine 5ml

Intervention Type: PROCEDURE

no phrenic block

no phrenic block

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dai Z Liang, Doctor

Role: STUDY_CHAIR

Shenzhen People's Hospital

Locations

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

daizhongliang-02

Identifier Type: -

Identifier Source: org_study_id