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

Not Applicable

Not yet recruiting

• Conditions: Lidocaine Spray; Intubation; Robotic Surgery
• Interventions: Drug: Normal Saline (0.9% NaCl); Drug: Lidocaine %2 ampoule

• Registration Number: NCT07154628
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study Start: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ASA classification I~III, age 18~69 y/o, BMI 18~35kg/m2, elective robotic surgery under general anesthesia

Exclusion Criteria

• Allergy or contraindication to lidocaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine group	Normal Saline (0.9% NaCl)	The group of patient will receive lidocaine spraying on vocal cord before intubation
Control group	Lidocaine %2 ampoule	The group of patient will receive normal saline spraying on vocal cord before intubation

Primary Outcome Measures

Name	Time	Method
post-intubation hypertension	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	From enrollment to the end of surgery
objective pain indices (Surgical Pleth Index)	From enrollment to the end of surgery

Secondary Outcome Measures

Name	Time	Method
post-intubation hypotension	From enrollment to postoperative day 1	defined as mean arterial pressure less than 70 mmHg
pain on swallowing	From enrollment to postoperative day 1	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.
postoperative sore throat	From enrollment to postoperative day 1	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.
hoarseness	From enrollment to postoperative day 1	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.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan