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NCT Number: NCT06122324

Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

Postoperative sore throat (POST) is a common outcome of general anesthesia in patients who undergo endotracheal intubation, and the estimated risk varies between 14.4% and 62%. It is one of the most undesirable postoperative anesthesia complications and has a negative impact on patient satisfaction and quality. Mucosal damage, inflammation, and erosion caused by endotracheal intubation all contribute to the development of POST. Therefore, POST is a condition that requires prevention and improvement.

In the study, patients will be divided into two groups. The investigators will include 100 patients undergoing surgery under general anesthesia. The first group will receive 150 mg of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive sterile distilled water as the control group.

Throat pain assessment will be conducted in patients at 2, 6, 12, and 24 hours after surgery.

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Key information

Conditions

Postoperative Sore Throat

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital

Kadiköy, Istanbul, Turkey (Türkiye)

About this study

Between November 2023 and December 2023, a total of 100 patients aged 18-65 with ASA 1-3 classification who are electively scheduled for laparoscopic cholecystectomy will participate in the study. Patients with ASA 4 or higher, those aged 65 and older, those under 18, and individuals with a known allergy to local anesthesia will not be included in the study. Patients who require intubation and are admitted to the intensive care unit or who experience mortality will be excluded from the study.

All patients will undergo preoperative assessment one day before the surgery, and written informed consent will be obtained for participation in the study. Patients will be randomly assigned to groups using a computer-generated randomization table. Patients in Group 1 will receive 150 mg (1,5ml) of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive terile distilled water (1,5ml) as the control group.

Demographic data, medical history, American Society of Anesthesiologists (ASA) classification, and pre- and post-lidocaine administration cardiac output (CO) and oxygen consumption (VO2), anesthesia time, surgical duration, as well as the occurrence of postoperative hypotension (systolic blood pressure decreased by more than 20% from baseline or SBP < 80 mmHg during surgery), nausea and vomiting, hypoxemia (SpO2 < 90% or PaO2 < 60 mmHg), hypercapnia (PaCO2 > 45 mmHg), and agitation during the awakening period will be recorded.

Throat pain will be assessed and recorded at postoperative hours 2, 6, 12, and 24. Throat pain will be evaluated using a throat pain scoring system ranging from 0 (no pain) to 3 (worst imaginable pain). After the surgery, all patients will be transferred to the post-anesthesia care unit (PACU).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • electively laparoscopic cholecystectomy.
  • ASA I-III,
  • between 18-65 years

Exclusion criteria

  • ASA IV and above
  • over 65 - under 18 years of age
  • lidocaine allergy

Treatment and study plan

Lidocaine Hydrochloride

Drug

Patients in Group 1 will receive lidocaine HCl solution 5 minutes before endotracheal intubation.

Drug (Placebo)

Drug

Sterile distilled water (1.5 mL) administration 5 minutes before intubation.

Primary outcomes

  1. The effect of lidocaine on postoperative sore throat

    Time frame: postoperative 24 hours

    The primary outcome of the study is to demonstrate whether lidocaine reduces postoperative sore throat. Sore throat and hoarseness of the patients were also investigated and recorded at the postoperative 0th, 2nd, 4th, and 24th hours. Sore throat was assessed with a scale as 0: no sore throat; 1: minimal sore throat (complaints of sore throat only on question); 2: moderate sore throat (accompanying sore throat); and 3: severe sore throat (voice change or hoarseness related to sore throat).

Secondary outcomes

  1. Effect of lidocaine on hemodynamic response

    Time frame: perioperative

    The secondary outcome of the study is to assess the impact of lidocaine on hemodynamic response. Before induction, after induction, after intubation at 1st and 5th minutes, and postoperative heart rate increase and blood pressure increase will be evaluated.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation of the Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Feb 27, 2026

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.

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