Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

NCT06122324 | Completed

• 1 other identifier: kartalanesthesia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Sore Throat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of lidocaine on hemodynamic response

  perioperative

Study Arms (2)

Lidocaine Group

EXPERIMENTAL

Five minutes before endotracheal intubation, 150 mg (1.5 mL) of 10% lidocaine HCl.

Drug: Lidocaine Hydrochloride

control group

PLACEBO COMPARATOR

Five minutes before endotracheal intubation, 1.5 mL sterile distilled water was administered.

Drug: Drug (Placebo)

Interventions

Lidocaine Hydrochloride DRUG

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

Lidocaine Group

Drug (Placebo) DRUG

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

control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

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

Kadiköy, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Lidocaine; Pharmaceutical Preparations

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist medical doctor anesthesiology and reanimation

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 8, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: February 27, 2026

Record last verified: 2025-02

Locations

TU (1)