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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2024-12-12

Brief Summary

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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

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Detailed Description

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This clinical trial is designed to evaluate the effects of two local anesthetic techniques on postoperative sore throat (POST) incidence and hemodynamic responses in patients undergoing elective thoracic surgery with double-lumen tube (DLT) intubation. POST is a common and undesirable outcome following general anesthesia with endotracheal intubation, particularly with DLTs due to their size and dual cuffs, which can increase mucosal irritation. Addressing POST effectively could significantly improve patient comfort, satisfaction, and overall quality of postoperative care.

\*\*Study Protocol Overview:\*\*

Patients meeting eligibility criteria (aged over 18, ASA I-III) will be recruited from Health Sciences University Kartal City Hospital and randomly assigned to one of three groups:

1. Group T (Inhaled Lidocaine): Participants will receive 2 ml of 10% lidocaine inhaled via a Tracheo-Spray device before anesthesia induction. This method is expected to coat the mucosal surfaces of the airway, potentially reducing friction and inflammation.
2. Group X (Lidocaine Applied to Tube): Participants will have 10% lidocaine sprayed directly on the distal surface and cuffs of the DLT. This technique aims to provide direct anesthetic coverage on the tube surface, potentially reducing mucosal damage from intubation.
3. Group C (Control): Participants will receive 1 ml of 0.9% saline spray as a placebo.

Data Collection:

The primary outcome measure will be the severity of POST, assessed at 2, 6, 12, and 24 hours postoperatively using a throat pain score (0 to 5 scale). Secondary measures will include hemodynamic parameters (heart rate, systolic and diastolic blood pressures) documented before and after lidocaine application, as well as the incidence of postoperative complications such as hypotension, hypoxemia, hypercapnia, nausea, vomiting, and emergence agitation. Trained investigators will collect data in the operating room, recovery room, and patient wards.

Statistical Analysis:

Data will be analyzed using descriptive and inferential statistics. The Kolmogorov-Smirnov test will assess the normality of data distribution. One-way ANOVA and Bonferroni or Tamhane post-hoc tests will be used for normally distributed variables. For non-parametric variables, the Kruskal-Wallis test and Mann-Whitney U test will be applied. Pearson's chi-square or Fisher's exact test will be used to evaluate qualitative variables, with significance set at p \< 0.05.

By comparing different application methods, this study aims to determine an effective approach for reducing POST, which could provide guidance for anesthetic practices in thoracic surgery involving DLTs.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Group T (Inhaled Lidocaine)

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

Group Type EXPERIMENTAL

Tracheo-Spray

Intervention Type DRUG

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

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

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

Group Type EXPERIMENTAL

Lidocaine Spray on DLT

Intervention Type DRUG

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

Group C (Control)

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

Group Type SHAM_COMPARATOR

Saline (Placebo)

Intervention Type 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).

Interventions

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Tracheo-Spray

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

Intervention Type DRUG

Lidocaine Spray on DLT

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

Intervention Type DRUG

Saline (Placebo)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No