Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine %2 ampoule, Normal Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Lidocaine Spray, Intubation, Robotic Surgery. Basic parameters: 18 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Lidocaine %2 ampoule
During general anesthesia, the anesthesiologist administers 1.5cc of lidocaine spraying on the vocal cords using Terumo SurfloTM I.V. Catheter 20G before intubation. - Drug 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.
Primary outcome measures
- post-intubation hypertension [Time frame: From enrollment to the end of surgery]
- 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
Identifiers
NCT: NCT07154628 · KMUHIRB-F(II)-20250221