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

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ClinicalTrials.gov Identifier: NCT03653494
Recruitment Status : Enrolling by invitation
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Shenzhen People's Hospital

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.

Condition or disease Intervention/treatment Phase
Phrenic Nerve Paralysis Procedure: phrenic block Procedure: no phrenic block Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Volunteers and data collectors was masked
Primary Purpose: Treatment
Official Title: Department of Anesthesiology in Shenzhen People's Hospital
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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




Primary Outcome Measures :
  1. the volume of anesthetic drugs [ Time Frame: the time of operation, an average of 4 hours ]
    the volume of anesthetic drugs including sevoflurane,propofol and opioids during the operation


Secondary Outcome Measures :
  1. the time to get out of bed after surgery [ Time Frame: two days after surgery ]
    note the time to get out of bed after surgery

  2. the cost of hospitalization [ Time Frame: the time of hospitalization, an average of 7 days ]
    note the the cost of hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653494


Locations
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China, Guangdong
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Sponsors and Collaborators
Shenzhen People's Hospital
Investigators
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Study Chair: Dai Z Liang, Doctor Shenzhen People's Hospital

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Responsible Party: Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT03653494    
Other Study ID Numbers: daizhongliang-02
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shenzhen People's Hospital:
non-intubated general anaesthesia
video-assisted thoracoscopic surgery
phrenic block
Additional relevant MeSH terms:
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Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs