Lidocaine SprayPhase 4NCT07154628
Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial
A Phase 4 study testing Lidocaine %2 ampoule and Normal Saline (0.9% NaCl) in people with Lidocaine Spray and Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Endotracheal intubation is a respiratory management technique used during general anesthesia. It is essential for certain surgical procedures as it ensures a secure airway for the patient. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Lidocaine Spray, Intubation, Robotic Surgery
- What is being tested?
- Lidocaine %2 ampoule and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA classification I~III
- aged 18~69 y/o
- BMI 18~35 kg/m2
- scheduled for elective robotic surgery under general anesthesia
Who cannot join
- Allergy or contraindication to lidocaine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kuang-I Cheng, PhD, 886-7-3121101 ext. 7035, kuaich@gmail.com
About this study
Endotracheal intubation is a respiratory management technique used during general anesthesia. It is essential for certain surgical procedures as it ensures a secure airway for the patient.
However, during the placement of the endotracheal tube, the passage of the tube through the vocal cords can cause pain stimulation, leading to an increase in heart rate and blood pressure. Lidocaine reversibly blocks the conduction of nerve impulses along nerve fibers by preventing the movement of sodium ions across the nerve membrane. Topical application of lidocaine near the vocal cords before endotracheal tube placement may be a way to reduce the surgical pleth index and changes in vital signs (heart rate, blood pressure) caused by excessive endotracheal tube stimulation.
This study aims to investigate the benefit of topical spraying of lidocaine on the vocal cords before endotracheal tube placement during routine da Vinci surgery. The primary outcomes were the pharmacological effects of spraying either lidocaine or normal saline (control group) on the vocal cords. These included: post-intubation hypertension (defined as an increase in systolic blood pressure of more than 20% from baseline), changes in mean arterial pressure before and after intubation, and objective pain indices such as the Surgical Pleth Index. Secondary outcomes included post-intubation hypotension (defined as mean arterial pressure less than 70 mmHg), as well as postoperative complaints and severity of sore throat, pain on swallowing, and hoarseness.
- Conditions
- Lidocaine Spray, Intubation, Robotic Surgery
- Being tested
- Lidocaine %2 ampoule, Normal Saline (0.9% NaCl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine %2 ampouleDrug
During general anesthesia, the anesthesiologist administers 1.5cc of lidocaine spraying on the vocal cords using Terumo SurfloTM I.V. Catheter 20G before intubation.
Normal Saline (0.9% NaCl)Drug
During general anesthesia, the anesthesiologist administers 1.5cc of normal saline spraying on the vocal cords using Terumo SurfloTM I.V. Catheter 20G before intubation.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Active comparator | The group of patient will receive lidocaine spraying on vocal cord before intubation Receives: Drug: Normal Saline (0.9% NaCl) |
| Control group | Placebo comparator | The group of patient will receive normal saline spraying on vocal cord before intubation Receives: Drug: Lidocaine %2 ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-intubation hypertension
defined as an increase in systolic blood pressure of more than 20% from baseline
Measured: From enrollment to the end of surgery
changes in mean arterial pressure before and after intubation
Measured: From enrollment to the end of surgery
objective pain indices (Surgical Pleth Index)
Measured: From enrollment to the end of surgery
Secondary outcomes (4)
post-intubation hypotension
defined as mean arterial pressure less than 70 mmHg
Measured: From enrollment to postoperative day 1
postoperative sore throat
During patients' stay in post-anesthetic care unit and our postoperative follow-up visiting at postoperative day 1, we will check the patients if they have any complaint of postoperative sore throat.
Measured: From enrollment to postoperative day 1
pain on swallowing
During patients' stay in post-anesthetic care unit and our postoperative follow-up visiting at postoperative day 1, we will check the patients if they have any complaint of pain on swallowing.
Measured: From enrollment to postoperative day 1
hoarseness
During patients' stay in post-anesthetic care unit and our postoperative follow-up visiting at postoperative day 1, we will check the patients if they have any complaint of hoarseness.
Measured: From enrollment to postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lidocaine SprayStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154628
- Sponsor's protocol ID
- KMUHIRB-F(II)-20250221
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: New analyses often require additional ethics committee approval.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07154628
- Acronym / sponsor ID
- KMUHIRB-F(II)-20250221
- Conditions
- Lidocaine Spray, Intubation, Robotic Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Sep 2025 (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.
Endotracheal intubation is a respiratory management technique used during general anesthesia. It is essential for certain surgical procedures as it ensures a secure airway for the patient.
However, during the placement of the endotracheal tube, the passage of the tube through the vocal cords can cause pain stimulation, leading to an increase in heart rate and blood pressure. Lidocaine reversibly blocks the conduction of nerve impulses along nerve fibers by preventing the movement of sodium ions across the nerve membrane. Topical application of lidocaine near the vocal cords before endotracheal tube placement may be a way to reduce the surgical pleth index and changes in vital signs (heart rate, blood pressure) caused by excessive endotracheal tube stimulation.
This study aims to investigate the benefit of topical spraying of lidocaine on the vocal cords before endotracheal tube placement during routine da Vinci surgery. The primary outcomes were the pharmacological effects of spraying either lidocaine or normal saline (control group) on the vocal cords. These included: post-intubation hypertension (defined as an increase in systolic blood pressure of more than 20% from baseline), changes in mean arterial pressure before and after intubation, and objective pain indices such as the Surgical Pleth Index. Secondary outcomes included post-intubation hypotension (defined as mean arterial pressure less than 70 mmHg), as well as postoperative complaints and severity of sore throat, pain on swallowing, and hoarseness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Active comparator | Drug: Normal Saline (0.9% NaCl)The group of patient will receive lidocaine spraying on vocal cord before intubation |
| Control group | Placebo comparator | Drug: Lidocaine %2 ampouleThe group of patient will receive normal saline spraying on vocal cord before intubation |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA classification I~III
- aged 18~69 y/o
- BMI 18~35 kg/m2
- scheduled for elective robotic surgery under general anesthesia
Key exclusion criteria (1 listed)
- Allergy or contraindication to lidocaine
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 |
|---|---|---|
| Lidocaine %2 ampouleDuring general anesthesia, the anesthesiologist administers 1.5cc of lidocaine spraying on the vocal cords using Terumo SurfloTM I.V. Catheter 20G before intubation. | Drug | Control group |
| Normal Saline (0.9% NaCl)During general anesthesia, the anesthesiologist administers 1.5cc of normal saline spraying on the vocal cords using Terumo SurfloTM I.V. Catheter 20G before intubation. | Drug | Lidocaine group |
Primary outcome
post-intubation hypertension
Time frame: From enrollment to the end of surgery
defined as an increase in systolic blood pressure of more than 20% from baseline
changes in mean arterial pressure before and after intubation
Time frame: From enrollment to the end of surgery
objective pain indices (Surgical Pleth Index)
Time frame: From enrollment to the end of surgery
4 secondary outcomes
post-intubation hypotension
Time frame: From enrollment to postoperative day 1
postoperative sore throat
Time frame: From enrollment to postoperative day 1
pain on swallowing
Time frame: From enrollment to postoperative day 1
hoarseness
Time frame: From enrollment to postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. New analyses often require additional ethics committee approval.
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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.
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 Lidocaine %2 ampoule and Normal Saline (0.9% NaCl) in people with Lidocaine Spray and Intubation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 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: opening soon, as of the sponsor's last update on 11 Sep 2025. 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 Taiwan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuh-Shyan Wu, MD (886-7-3121101 ext. 7035, cindy12012991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-intubation hypertension (time frame: From enrollment to the end of surgery). The study lists 3 primary outcomes in all. 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 11 Sep 2025.