Lung CancerPhase 4NCT03302221
Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound
A Phase 4 study testing 0.5% ropivacaine paravertebral block, 0.25% ropivacaine epidural block and 0.5% ropivacaine local anaesthesia in people with Lung Cancer, run by China Medical University, China at 1 site in China.
Trial summary
The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 0.5% ropivacaine paravertebral block, 0.25% ropivacaine epidural block and 0.5% ropivacaine local anaesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2017to 20 Sep 2020
- Phase
- Phase 4
- 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
- ethnic Chinese;
- age, 18 to 65 years old;
- American Society of Anaesthesiologists (ASA) physical status I or II;
- required VATS for lung surgery and one lung ventilation .
Who cannot join
- body mass index exceeding 30 kg/m2; Patients with a history of hypertension, diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.
- Patients with arrhythmias or implanted cardiac pacemakers were excluded. Patients with diseases of the central or peripheral nervous system were excluded.
- Patients taking medications affecting the autonomic nervous system, such as b-blockers and calcium channel blockers
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management
The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management.
Read the detailed description
The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management. The patients in this trial were visited during the entire operation and just before leaving the post-anaesthesia care unit. Velocity-associated data related to pulsed-wave Doppler ultrasound and the consumption of phenylephrine were collected.
- Conditions
- Lung Cancer
- Being tested
- 0.5% ropivacaine paravertebral block, 0.25% ropivacaine epidural block, 0.5% ropivacaine local anaesthesia
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% ropivacaine paravertebral blockDrug
The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block
0.25% ropivacaine epidural blockDrug
A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.
0.5% ropivacaine local anaesthesiaDrug
local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group control | Other | In the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery. Receives: Drug: 0.5% ropivacaine local anaesthesia |
| Paravertebral Block Group | Experimental | In Group Paravertebral Block, patients received standardized general anaesthesia supplemented by paravertebral Block. The USG approach for TPVB was used with the patient in the lateral position at the T4-T6 level according to the incision protocol in our centre. Receives: Drug: 0.5% ropivacaine paravertebral block |
| Epidural Block Group | Experimental | The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography ;general anesthesia combined with epidural block Receives: Drug: 0.25% ropivacaine epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of end-diastolic velocity
The primary outcome was the end-diastolic velocity at 12 time points of anaesthesia induction among the three groups.
Measured: baseline and 10 minutes after induction
Secondary outcomes (2)
pulsed-wave Doppler ultrasound
other data related to pulsed-wave Doppler ultrasound and acquired during anaesthesia induction, before leaving the PACU and during inspiratory cough
Measured: before leaving the PACU, up to 5 minutes
intraoperative consumption of phenylephrine
intraoperative consumption of phenylephrine
Measured: through study completion, an average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start15 Oct 2017
- Primary completion20 Aug 2020 (estimated)
- Study completion20 Sep 2020 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Doppler Ultrasonography Assessed Vascular Changes
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Hong Ma, MD,PhD, Study chair, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302221
- Sponsor's protocol ID
- 20170711-01
- Status last verified
- Mar 2020
- First submitted
- 1 Oct 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Haemodynamic Changes in Radial Artery Assessment With Continuous Pulsed-wave Doppler Ultrasound in Patients Undergoing Video-assisted Thoracic Surgery With Different Kinds of Anaesthesia Management
- ClinicalTrials.gov ID
- NCT03302221
- Acronym / sponsor ID
- 20170711-01
- Conditions
- Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 20 Aug 2020 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 5 Oct 2017 (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.
The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management.
Detailed description
The objective of the trial was to evaluate velocity-associated parameters of pulsed-wave Doppler ultrasound at induction, discharge from the post-anaesthesia care unit and during inspiratory cough in addition to the consumption of phenylephrine during the operation in patients undergoing video-assisted thoracic surgery with three types of anaesthesia management. The patients in this trial were visited during the entire operation and just before leaving the post-anaesthesia care unit. Velocity-associated data related to pulsed-wave Doppler ultrasound and the consumption of phenylephrine were collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Doppler Ultrasonography Assessed Vascular Changes
| Arm | Type | Receives |
|---|---|---|
| Group control | Other | Drug: 0.5% ropivacaine local anaesthesiaIn the control group, local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery. |
| Paravertebral Block Group | Experimental | Drug: 0.5% ropivacaine paravertebral blockIn Group Paravertebral Block, patients received standardized general anaesthesia supplemented by paravertebral Block. The USG approach for TPVB was used with the patient in the lateral position at the T4-T6 level according to the incision protocol in our centre. |
| Epidural Block Group | Experimental | Drug: 0.25% ropivacaine epidural blockThe investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography ;general anesthesia combined with epidural block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ethnic Chinese;
- age, 18 to 65 years old;
- American Society of Anaesthesiologists (ASA) physical status I or II;
- required VATS for lung surgery and one lung ventilation .
Key exclusion criteria (3 listed)
- body mass index exceeding 30 kg/m2; Patients with a history of hypertension, diabetes mellitus or arteriosclerosis; and any allergy to drugs used in the study.
- Patients with arrhythmias or implanted cardiac pacemakers were excluded. Patients with diseases of the central or peripheral nervous system were excluded.
- Patients taking medications affecting the autonomic nervous system, such as b-blockers and calcium channel blockers
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 |
|---|---|---|
| 0.5% ropivacaine paravertebral blockThe investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block | Drug | Paravertebral Block Group |
| 0.25% ropivacaine epidural blockA 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB. | Drug | Epidural Block Group |
| 0.5% ropivacaine local anaesthesialocal anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery. | Drug | Group control |
Primary outcome
The Change of end-diastolic velocity
Time frame: baseline and 10 minutes after induction
The primary outcome was the end-diastolic velocity at 12 time points of anaesthesia induction among the three groups.
2 secondary outcomes
pulsed-wave Doppler ultrasound
Time frame: before leaving the PACU, up to 5 minutes
intraoperative consumption of phenylephrine
Time frame: through study completion, an average of 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Cancer
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Ovarian Cancer, Non-small Cell Lung Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
Active, not recruitingPhase 3
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Advanced or Metastatic Non-small Cell Lung Cancer
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.
Hong Ma, MD,PhD study chair
Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.5% ropivacaine paravertebral block, 0.25% ropivacaine epidural block and 0.5% ropivacaine local anaesthesia in people with Lung Cancer, run by China Medical University, China 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 Mar 2020. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Change of end-diastolic velocity (time frame: baseline and 10 minutes after induction). 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 10 Mar 2020.