Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

Evaluation of the 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Sore Throat
• Intervention / Treatment: Drug: Lidocaine Hydrochloride; Drug: Drug (Placebo)

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Kadiköy, Istanbul, Turkey (Türkiye)
      • University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

A total of 100 patients aged 18-65 with ASA 1-3 classification will participate in the study, undergoing elective laparoscopic cholecystectomy.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Group; Five minutes before endotracheal intubation, 150 mg (1.5 mL) of 10% lidocaine HCl.	Drug: Lidocaine Hydrochloride; Patients in Group 1 will receive lidocaine HCl solution 5 minutes before endotracheal intubation.
Placebo Comparator: control group; Five minutes before endotracheal intubation, 1.5 mL sterile distilled water was administered.	Drug: Drug (Placebo); Sterile distilled water (1.5 mL) administration 5 minutes before intubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of lidocaine on postoperative sore throat	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).	postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of lidocaine on hemodynamic response	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.	perioperative

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Principal Investigator: hülya yılmaz ak, Kartal Dr Lutfi Kırdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pharyngitis; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine; Pharmaceutical Preparations
• Other Study ID Numbers: kartalanesthesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No