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Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial

Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07154628
Enrollment
80
Registered
2025-09-04
Start date
2025-09-01
Completion date
2028-12-31
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lidocaine Spray, Intubation, Robotic Surgery

Brief 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. 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.

Interventions

During general anesthesia, the anesthesiologist administers 1.5cc of lidocaine spraying on the vocal cords using Terumo SurfloTM I.V. Catheter 20G before intubation.

DRUGNormal 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.

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* ASA classification I\ III * aged 18\ 69 y/o * BMI 18\ 35 kg/m2 * scheduled for elective robotic surgery under general anesthesia

Exclusion criteria

* Allergy or contraindication to lidocaine

Design outcomes

Primary

MeasureTime frameDescription
post-intubation hypertensionFrom enrollment to the end of surgerydefined as an increase in systolic blood pressure of more than 20% from baseline
changes in mean arterial pressure before and after intubationFrom enrollment to the end of surgery
objective pain indices (Surgical Pleth Index)From enrollment to the end of surgery

Secondary

MeasureTime frameDescription
post-intubation hypotensionFrom enrollment to postoperative day 1defined as mean arterial pressure less than 70 mmHg
hoarsenessFrom enrollment to postoperative day 1During 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.
postoperative sore throatFrom enrollment to postoperative day 1During 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.
pain on swallowingFrom enrollment to postoperative day 1During 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.

Countries

Taiwan

Contacts

Primary ContactYuh-Shyan Wu, MD
cindy12012991@gmail.com886-7-3121101
Backup ContactI-Cheng Lu, PhD
u9251112@gmail.com886-7-3121101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026