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

NCT07154628 | Not Yet Recruiting Phase 4

• 1 other identifier: KMUHIRB-F(II)-20250221
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lidocaine Spray; Intubation; Robotic Surgery

Outcome Measures

Primary Outcomes (3)

• post-intubation hypertension

  defined as an increase in systolic blood pressure of more than 20% from baseline

  From enrollment to the end of surgery

• 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 Outcomes (4)

• post-intubation hypotension

  From enrollment to postoperative day 1

• postoperative sore throat

  From enrollment to postoperative day 1

• pain on swallowing

  From enrollment to postoperative day 1

• hoarseness

  From enrollment to postoperative day 1

Study Arms (2)

Lidocaine group

ACTIVE COMPARATOR

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

Drug: Normal Saline (0.9% NaCl)

Control group

PLACEBO COMPARATOR

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

Drug: Lidocaine %2 ampoule

Interventions

Lidocaine %2 ampoule DRUG

During general anesthesia, the anesthesiologist administers 1.5cc of lidocaine spraying on the vocal cords using Terumo SurfloTM I.V. Catheter 20G before intubation.

Control group

Normal Saline (0.9% NaCl) DRUG

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.

Lidocaine group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA classification I\~III
• aged 18\~69 y/o
• BMI 18\~35 kg/m2
• scheduled for elective robotic surgery under general anesthesia

You may not qualify if:

• Allergy or contraindication to lidocaine

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Yuh-Shyan Wu, MD

CONTACT

886-7-3121101; cindy12012991@gmail.com

I-Cheng Lu, PhD

CONTACT

886-7-3121101; u9251112@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)