The Effect of Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Double-Lumen Tubes

NCT06705595 | Completed

• 1 other identifier: LA&Double-LumenTubes
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to determine if different local anesthetic application techniques can reduce postoperative sore throat (POST) and manage hemodynamic responses in adult patients undergoing elective thoracic surgery with double-lumen intubation. The main questions it aims to answer are:

• Does inhaled lidocaine or lidocaine applied to the double-lumen tube reduce the incidence and severity of POST?
• How do these anesthetic techniques impact hemodynamic stability during surgery? Researchers will compare three groups-those receiving inhaled lidocaine, lidocaine applied to the tube, and a saline control group-to see if these methods differ in effectiveness. Participants will:
• Undergo standard preoperative assessment and provide informed consent
• Be randomly assigned to receive either inhaled lidocaine, lidocaine applied to the tube, or saline
• Have sore throat scores and hemodynamic data recorded at specific intervals after surgery

Conditions

Anesthesia, Local; Intubation, Intratracheal; Double-lumen Tube; Sore Throat; Lidocaine Spray

Keywords

Double-lumen tube; Lidocaine; Sore throat; Lidocaine spray

Outcome Measures

Primary Outcomes (1)

• Postoperative Sore Throat (POST)

  The severity of POST will be assessed at 2, 6, 12, and 24 hours after surgery using a throat pain score, ranging from 0 (no pain) to 5 (worst imaginable pain).

  2, 6, 12, and 24 hours after surgery

Secondary Outcomes (1)

• Intraperative Hemodynamic Responses

  Basal measurements and 5 minutes after intubation.

Other Outcomes (1)

• Postoperative Complications:

  Postoperative 2. 6. 12. and 24. hours

Study Arms (3)

Group T (Inhaled Lidocaine)

EXPERIMENTAL

Participants will receive 2 ml of 10% lidocaine via a Tracheo-Spray device before anesthesia induction.

Drug: Tracheo-Spray

Group X (Lidocaine Applied to the Double-Lumen Tube):

EXPERIMENTAL

Participants will receive 10% lidocaine sprayed directly onto the distal surface and cuffs of the double-lumen tube.

Drug: Lidocaine Spray on DLT

Group C (Control)

SHAM COMPARATOR

Participants will receive 1 ml of 0.9% saline as a placebo.

Drug: Saline (Placebo)

Interventions

Tracheo-Spray DRUG

Participants will receive 2 ml of 10% lidocaine delivered via a Tracheo-Spray device to the tracheal mucosa before anesthesia induction.

Group T (Inhaled Lidocaine)

Lidocaine Spray on DLT DRUG

Before intubation, participants will receive 10% lidocaine spray applied to the distal surface and cuffs of the double-lumen tube (DLT).

Group X (Lidocaine Applied to the Double-Lumen Tube):

Saline (Placebo) DRUG

Before intubation, participants will receive 1 ml of 0.9% saline applied to the distal surface and cuffs of the double-lumen tube (DLT).

Group C (Control)

Eligibility Criteria

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

You may qualify if:

• Aged over 18 years
• ASA (American Society of Anesthesiologists) scores of 1-3
• Elective thoracic surgery patients

You may not qualify if:

• Patients with ASA scores of 4 or above
• Do not consent to participate
• individuals with mental disorders
• patients under 18 years of age
• surgeries exceeding two hours
• those with known allergies to local anesthetic

Sponsors & Collaborators

• V.K.V. American Hospital, Istanbul: lead

Study Sites (1)

Health Sciences University Kartal City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Chandler M. Tracheal intubation and sore throat: a mechanical explanation. Anaesthesia. 2002 Feb;57(2):155-61. doi: 10.1046/j.1365-2044.2002.02329.x.

  PMID: 11871952 BACKGROUND

• Tanaka Y, Nakayama T, Nishimori M, Tsujimura Y, Kawaguchi M, Sato Y. Lidocaine for preventing postoperative sore throat. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD004081. doi: 10.1002/14651858.CD004081.pub3.

  PMID: 26171894 BACKGROUND

• El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.

  PMID: 27158989 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statisticians: The statisticians analyzing the data will remain blinded to the group assignments during the initial stages of analysis to avoid any bias in the interpretation of the results. Unblinding will occur only after the data is fully collected and the analysis plan is in place. Data Collection Staff: The staff collecting data in the operating room, recovery room, and patient wards (e.g., monitoring vital signs and postoperative complications) will be blinded to the specific treatment group of the patient. This minimizes any potential bias during the collection of clinical data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 26, 2024
• Study Start: November 6, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 12, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The start date for IPD sharing will be after the completion of the study and the publication of the main study results, approximately June 2025. End Date for IPD Sharing: IPD will be available for sharing for a period of 5 years following the publication of the study results, until June 2030. During this period, researchers who meet the criteria for access will be able to request the de-identified data for secondary analyses.

Locations

TU (1)