NCT07154628

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

Not yet recruiting Phase 4 Last updated 11 September 2025

What this trial tests

Phase 4 trial testing Lidocaine %2 ampoule in Lidocaine Spray in 80 participants. Not yet recruiting.

Timeline

1 September 2025

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Kaohsiung Medical University Chung-Ho Memorial Hospital
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	80
Start date	1 September 2025
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across Taiwan

Drugs / interventions tested

• Lidocaine %2 ampoule — full drug profile →
• Normal Saline (0.9% NaCl) — full drug profile →

Conditions studied

• Lidocaine Spray — all drugs for Lidocaine Spray →
• Intubation — all drugs for Intubation →
• Robotic Surgery — all drugs for Robotic Surgery →

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Who can join

Adults 18 to 69, any sex, with Lidocaine Spray or Intubation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.