Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07154628

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location contact

Kuang-I Cheng, PhD

CONTACT

[email protected]

886-7-3121101 ext. 7035

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. post-intubation hypertension

    Time frame: From enrollment to the end of surgery

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

  2. changes in mean arterial pressure before and after intubation

    Time frame: From enrollment to the end of surgery

  3. objective pain indices (Surgical Pleth Index)

    Time frame: From enrollment to the end of surgery

Secondary outcomes

  1. post-intubation hypotension

    Time frame: From enrollment to postoperative day 1

    defined as mean arterial pressure less than 70 mmHg

  2. postoperative sore throat

    Time frame: 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.

  3. pain on swallowing

    Time frame: 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.

  4. hoarseness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

I-Cheng Lu, PhD

CONTACT

[email protected]

886-7-3121101 ext. 7035

Yuh-Shyan Wu, MD

CONTACT

[email protected]

886-7-3121101 ext. 7035

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.