Lung NeoplasmsPhase 4NCT05850702
Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine
A Phase 4 study testing Lidocaine and Saline in people with Lung Neoplasms, run by RenJi Hospital.
Trial summary
The goal of this clinical trial is to test the effect of nebulized lidocaine on the hemodynamic response in the participant undergoing double-lumen endotracheal intubation. The main question it aims to answer is to evaluate the changes in mean arterial pressure after intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Lidocaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 9 Sep 2025
- 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
- aged 18-65 years, American Society of Anesthesiologists class I-II
- participants undergoing double-lumen endotracheal intubation under general anesthesia
- signed informed consent and volunteered to participate in the experiment
Who cannot join
- Poor control of hypertension
- preoperative arrhythmia
- severe coronary artery or heart valve disease
- sequelae of cerebrovascular accident
- severe lung, liver, kidney and immune system diseases
- Suspected difficult airway
- confirmed or suspected allergy to this trial drug
- As judged by the investigator to be ineligible for the study, such as communication impairment (language or intelligence)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine: a Randomized, Double-blind, Controlled Trial
The goal of this clinical trial is to test the effect of nebulized lidocaine on the hemodynamic response in the participant undergoing double-lumen endotracheal intubation.
The main question it aims to answer is to evaluate the changes in mean arterial pressure after intubation.
Participants will inhale 5ml of 2% lidocaine by nebulization15min before intubation.
Researchers will compare saline group to see if saline effects
- Conditions
- Lung Neoplasms
- Being tested
- Lidocaine, Saline
- Keywords
- Double-lumen Endotracheal Intubation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
inhale 5ml of 2% lidocaine by nebulization
SalineDrug
inhale 5ml of saline by nebulization
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | Intervention group Receives: Drug: Lidocaine |
| saline | Placebo comparator | control group Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean arterial pressure after intubation
Measured: Immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion9 Mar 2025 (estimated)
- Study completion9 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhuhao, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850702
- Sponsor's protocol ID
- IIT-2022-0250
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuation of the Hemodynamic Response to Double-lumen Endotracheal Intubation With Nebulized Lidocaine: a Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05850702
- Acronym / sponsor ID
- IIT-2022-0250
- Conditions
- Lung Neoplasms
- Keywords
- Double-lumen Endotracheal Intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 9 Mar 2025 (estimated)
- Study completion
- 9 Sep 2025 (estimated)
- First posted
- 9 May 2023 (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 goal of this clinical trial is to test the effect of nebulized lidocaine on the hemodynamic response in the participant undergoing double-lumen endotracheal intubation.
The main question it aims to answer is to evaluate the changes in mean arterial pressure after intubation.
Participants will inhale 5ml of 2% lidocaine by nebulization15min before intubation.
Researchers will compare saline group to see if saline effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: LidocaineIntervention group |
| saline | Placebo comparator | Drug: Salinecontrol group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-65 years, American Society of Anesthesiologists class I-II
- participants undergoing double-lumen endotracheal intubation under general anesthesia
- signed informed consent and volunteered to participate in the experiment
Key exclusion criteria (8 listed)
- Poor control of hypertension
- preoperative arrhythmia
- severe coronary artery or heart valve disease
- sequelae of cerebrovascular accident
- severe lung, liver, kidney and immune system diseases
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 |
|---|---|---|
| Lidocaineinhale 5ml of 2% lidocaine by nebulization | Drug | lidocaine |
| Salineinhale 5ml of saline by nebulization | Drug | saline |
Primary outcome
mean arterial pressure after intubation
Time frame: Immediately after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Saline in people with Lung Neoplasms, run by RenJi Hospital.
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 3 inclusion and 8 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhu (008602168383702, zhuhaossmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean arterial pressure after intubation (time frame: Immediately after intubation). 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 9 May 2023.