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

Kaohsiung Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Lidocaine Spray; Intubation; Robotic Surgery

Treatments: Drug: Lidocaine %2 ampoule; Drug: Normal Saline (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT07154628

KMUHIRB-F(II)-20250221

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

80 participants in 2 patient groups, including a placebo group

Lidocaine group

Active Comparator group

Description:

The group of patient will receive lidocaine spraying on vocal cord before intubation

Treatment:

Drug: Normal Saline (0.9% NaCl)

Control group

Placebo Comparator group

Description:

The group of patient will receive normal saline spraying on vocal cord before intubation

Treatment:

Drug: Lidocaine %2 ampoule