Phrenic Nerve ParalysisEarly Phase 1NCT03653494
the Clinicaltrail of the Effection Which of Phrenic Block Using in Non-intubated Video-assisted Thoracoscopic Surgery
A Early Phase 1 study testing phrenic block and no phrenic block in people with Phrenic Nerve Paralysis, run by Shenzhen People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phrenic Nerve Paralysis
- What is being tested?
- phrenic block and no phrenic block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 31 Dec 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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.
- Compare the volume of anesthetic drugs 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
- Being tested
- phrenic block, no phrenic block
- Keywords
- non-intubated general anaesthesia, video-assisted thoracoscopic surgery, phrenic block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phrenic blockProcedure or surgery
phrenic block by 1% ropivacaine 5ml
no phrenic blockProcedure or surgery
no phrenic block
| Study group | Role | What they receive |
|---|---|---|
| phrenic block group | Experimental | non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block Receives: Procedure: phrenic block |
| Control group | Active comparator | non-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block Receives: Procedure: no phrenic block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the volume of anesthetic drugs
the volume of anesthetic drugs including sevoflurane,propofol and opioids during the operation
Measured: the time of operation， an average of 4 hours
Secondary outcomes (2)
the time to get out of bed after surgery
note the time to get out of bed after surgery
Measured: two days after surgery
the cost of hospitalization
note the the cost of hospitalization
Measured: the time of hospitalization， an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phrenic Nerve ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dai Z Liang, Doctor, Study chair, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653494
- Sponsor's protocol ID
- daizhongliang-02
- Status last verified
- May 2018
- First submitted
- 16 Jul 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Anesthesiology in Shenzhen People's Hospital
- ClinicalTrials.gov ID
- NCT03653494
- Acronym / sponsor ID
- daizhongliang-02
- Conditions
- Phrenic Nerve Paralysis
- Keywords
- non-intubated general anaesthesia, video-assisted thoracoscopic surgery, phrenic block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Compare the volume of anesthetic drugs 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| phrenic block group | Experimental | Procedure: phrenic blocknon-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia、Vagus block and Phrenic block |
| Control group | Active comparator | Procedure: no phrenic blocknon-intubated general anesthesia combine with Paravertebral blocks、surface spray anesthesia and Vagus block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- Mallampati≥3.
- BMI≥26 kg/m2.
- Hemodynamic instability.
- INR≥1.5.
- Respiratory infection, persistent cough or airway mucus hypersecretion, high risk of reflux.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phrenic blockphrenic block by 1% ropivacaine 5ml | Procedure or surgery | phrenic block group |
| no phrenic blockno phrenic block | Procedure or surgery | Control group |
Primary outcome
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
2 secondary outcomes
the time to get out of bed after surgery
Time frame: two days after surgery
the cost of hospitalization
Time frame: the time of hospitalization， an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dai Z Liang, Doctor study chair
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing phrenic block and no phrenic block in people with Phrenic Nerve Paralysis, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the volume of anesthetic drugs (time frame: the time of operation， an average of 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.