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

Department of Anesthesiology in Shenzhen People's Hospital

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.

Study Overview

• Status: Unknown
• Conditions: Phrenic Nerve Paralysis
• Intervention / Treatment: Procedure: phrenic block; Procedure: no phrenic block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • Shenzhen People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: phrenic block group; non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block	Procedure: phrenic block; phrenic block by 1% ropivacaine 5ml
Active Comparator: Control group; non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block	Procedure: no phrenic block; no phrenic block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	the time of hospitalization， an average of 7 days

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Study Chair: Dai Z Liang, Doctor, Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: video-assisted thoracoscopic surgery; non-intubated general anaesthesia; phrenic block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis
• Other Study ID Numbers: daizhongliang-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No