Anesthesia, LocalNCT06705595
The Effect of Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Double-Lumen Tubes
A study testing Tracheo-Spray and Lidocaine Spray on DLT in people with Anesthesia, Local and Intubation, Intratracheal, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Intubation, Intratracheal, Double-lumen Tube
- What is being tested?
- Tracheo-Spray and Lidocaine Spray on DLT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Nov 2024to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years
- ASA (American Society of Anesthesiologists) scores of 1-3
- Elective thoracic surgery patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Kartal City Hospital
Istanbul
About this study
Official title: The Effect of Two Different Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Patients Intubated With Double-Lumen Tubes: A Randomized Controlled Study
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?
Read more
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
Read the detailed description
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:
- 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.
- 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.
- 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
- Anesthesia, Local, Intubation, Intratracheal, Double-lumen Tube, Sore Throat, Lidocaine Spray
- Being tested
- Tracheo-Spray, Lidocaine Spray on DLT, Saline (Placebo)
- Keywords
- Double-lumen tube, Lidocaine, Sore throat, Lidocaine spray
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheo-SprayDrug
Participants will receive 2 ml of 10% lidocaine delivered via a Tracheo-Spray device to the tracheal mucosa before anesthesia induction.
Lidocaine Spray on DLTDrug
Before intubation, participants will receive 10% lidocaine spray applied to the distal surface and cuffs of the double-lumen tube (DLT).
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).
| Study group | Role | What they receive |
|---|---|---|
| Group T (Inhaled Lidocaine) | Experimental | Participants will receive 2 ml of 10% lidocaine via a Tracheo-Spray device before anesthesia induction. Receives: 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. Receives: Drug: Lidocaine Spray on DLT |
| Group C (Control) | Sham comparator | Participants will receive 1 ml of 0.9% saline as a placebo. Receives: Drug: Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2, 6, 12, and 24 hours after surgery
Secondary outcomes (1)
Intraperative Hemodynamic Responses
Hypotension: Defined as a decrease of more than 20% in systolic blood pressure from baseline or < 80 mmHg.
Hypertension: Defined as an increase of more than 20% in systolic blood pressure from baseline or > 120 mmHg.
Measured: Basal measurements and 5 minutes after intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start6 Nov 2024
- Primary completion6 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Tümer, MD, V.K.V. American Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705595
- Sponsor's protocol ID
- LA&Double-LumenTubes
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that will be shared includes the following: Demographic Information, Postoperative Sore Throat (POST) Scores, Hemodynamic Data, and Intraoperative Complications. All shared data will be de-identified to protect participant confidentiality, and access will be granted only to researchers who meet the necessary criteria and ethical standards for data use.
Publications
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.
PubMed 11871952Tanaka 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.
PubMed 26171894El-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.
PubMed 27158989
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Patients Intubated With Double-Lumen Tubes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06705595
- Acronym / sponsor ID
- LA&Double-LumenTubes
- Conditions
- Anesthesia, Local, Intubation, Intratracheal, Double-lumen Tube, Sore Throat, Lidocaine Spray
- Keywords
- Double-lumen tube, Lidocaine, Sore throat, Lidocaine spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group T (Inhaled Lidocaine) | Experimental | Drug: Tracheo-SprayParticipants will receive 2 ml of 10% lidocaine via a Tracheo-Spray device before anesthesia induction. |
| Group X (Lidocaine Applied to the Double-Lumen Tube): | Experimental | Drug: Lidocaine Spray on DLTParticipants will receive 10% lidocaine sprayed directly onto the distal surface and cuffs of the double-lumen tube. |
| Group C (Control) | Sham comparator | Drug: Saline (Placebo)Participants will receive 1 ml of 0.9% saline as a placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18 years
- ASA (American Society of Anesthesiologists) scores of 1-3
- Elective thoracic surgery patients
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracheo-SprayParticipants will receive 2 ml of 10% lidocaine delivered via a Tracheo-Spray device to the tracheal mucosa before anesthesia induction. | Drug | Group T (Inhaled Lidocaine) |
| Lidocaine Spray on DLTBefore intubation, participants will receive 10% lidocaine spray applied to the distal surface and cuffs of the double-lumen tube (DLT). | Drug | Group X (Lidocaine Applied to the Double-Lumen Tube): |
| 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). | Drug | Group C (Control) |
Primary outcome
Postoperative Sore Throat (POST)
Time frame: 2, 6, 12, and 24 hours after surgery
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).
1 secondary outcome
Intraperative Hemodynamic Responses
Time frame: Basal measurements and 5 minutes after intubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Results publication: PubMed 11871952Chandler 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.
- Results publication: PubMed 26171894Tanaka 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.
- Results publication: PubMed 27158989El-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.
- Individual participant dataSharing planned: Yes. The data that will be shared includes the following: Demographic Information, Postoperative Sore Throat (POST) Scores, Hemodynamic Data, and Intraoperative Complications. All shared data will be de-identified to protect participant confidentiality, and access will be granted only to researchers who meet the necessary criteria and ethical standards for data use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheo-Spray and Lidocaine Spray on DLT in people with Anesthesia, Local and Intubation, Intratracheal, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Sore Throat (POST) (time frame: 2, 6, 12, and 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705595, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.