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

NCT03653494 | Unknown Early Phase 1 DMC

• 1 other identifier: daizhongliang-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Phrenic Nerve Paralysis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the time to get out of bed after surgery

  two days after surgery

• the cost of hospitalization

  the time of hospitalization， an average of 7 days

Study Arms (2)

phrenic block group

EXPERIMENTAL

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

Procedure: phrenic block

Control group

ACTIVE COMPARATOR

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

Procedure: no phrenic block

Interventions

phrenic block PROCEDURE

phrenic block by 1% ropivacaine 5ml

phrenic block group

no phrenic block PROCEDURE

no phrenic block

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

Study Officials

• Dai Z Liang, Doctor

  Shenzhen People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Volunteers and data collectors was masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 16, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)