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

Phrenic Nerve Paralysis Clinical Trial

Official title:

Department of Anesthesiology in Shenzhen People's Hospital

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03653494
• Other study ID #: daizhongliang-02
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: October 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2018
• Source: Shenzhen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paralysis
• Phrenic Nerve Paralysis

Intervention

Procedure:
• phrenic block
phrenic block by 1% ropivacaine 5ml
• no phrenic block
no phrenic block

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the time to get out of bed after surgery	note the time to get out of bed after surgery	two days after surgery
Secondary	the cost of hospitalization	note the the cost of hospitalization	the time of hospitalization, an average of 7 days