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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-69
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA classification I~III

aged 18~69 y/o

BMI 18~35 kg/m2

scheduled for elective robotic surgery under general anesthesia

Disqualifiers

Allergy or contraindication to lidocaine

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Lidocaine groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

post-intubation hypertension

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

Time frame
From enrollment to the end of surgery
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

defined as mean arterial pressure less than 70 mmHg

Time frame
From enrollment to postoperative day 1
2

postoperative sore throat

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.

Time frame
From enrollment to postoperative day 1
3

pain on swallowing

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.

Time frame
From enrollment to postoperative day 1
4

hoarseness

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.

Time frame
From enrollment to postoperative day 1

Other outcomes

Sponsors and contacts

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