Effect of Topical Lidocaine Spraying on the Vocal Cords Before Intubation During Robotic Surgery: a Randomized Controlled Trial
NCT ID: NCT07154628
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2025-09-01
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lidocaine group
The group of patient will receive lidocaine spraying on vocal cord before intubation
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.
Control group
The group of patient will receive normal saline spraying on vocal cord before intubation
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* aged 18\~69 y/o
* BMI 18\~35 kg/m2
* scheduled for elective robotic surgery under general anesthesia
Exclusion Criteria
18 Years
69 Years
ALL
No
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Responsible Party
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Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KMUHIRB-F(II)-20250221
Identifier Type: -
Identifier Source: org_study_id
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