Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat

NCT ID: NCT06122324

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-06-30

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 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive standard anesthesia management as the control group.

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

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 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive standard anesthesia management 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).

Conditions

Postoperative Sore Throat

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

lidocaine group

Patients in Group 1 will receive 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation.

Lidocaine Hydrochloride

Intervention Type: DRUG

Patients in Group 1 will receive 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation.

control group

The second group will receive standard anesthesia management as the control group.

No interventions assigned to this group

Interventions

Lidocaine Hydrochloride

Patients in Group 1 will receive 40 mg of lidocaine HCl solution 5 minutes before endotracheal intubation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

kübra taşkın

specialist medical doctor anesthesiology and reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hülya yılmaz ak

Role: PRINCIPAL_INVESTIGATOR

Kartal Dr Lutfi Kırdar City Hospital

Locations

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

Kadiköy, İ̇stanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

kartalanesthesia

Identifier Type: -

Identifier Source: org_study_id