Postoperative Sore ThroatNCT06122324
Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat
A study testing Lidocaine Hydrochloride in people with Postoperative Sore Throat, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Sore Throat
- What is being tested?
- Lidocaine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- electively laparoscopic cholecystectomy.
- ASA I-III,
- between 18-65 years
Who cannot join
- ASA IV and above
- over 65 - under 18 years of age
- lidocaine allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital
Kadiköy, Istanbul
About this study
Official title: Evaluation of the Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat
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.
Read the 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 150 mg (1,5ml) of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive terile distilled water (1,5ml) 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
- Being tested
- Lidocaine Hydrochloride, Drug (Placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
Patients in Group 1 will receive lidocaine HCl solution 5 minutes before endotracheal intubation.
Drug (Placebo)Drug
Sterile distilled water (1.5 mL) administration 5 minutes before intubation.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Five minutes before endotracheal intubation, 150 mg (1.5 mL) of 10% lidocaine HCl. Receives: Drug: Lidocaine Hydrochloride |
| control group | Placebo comparator | Five minutes before endotracheal intubation, 1.5 mL sterile distilled water was administered. Receives: Drug: Drug (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: postoperative 24 hours
Secondary outcomes (1)
Effect of lidocaine on hemodynamic response
The secondary outcome of the study is to assess the impact of lidocaine on hemodynamic response. Before induction, after induction, after intubation at 1st and 5th minutes, and postoperative heart rate increase and blood pressure increase will be evaluated.
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, kübra taşkın, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122324
- Sponsor's protocol ID
- kartalanesthesia
- Status last verified
- Feb 2025
- First submitted
- 1 Nov 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT06122324
- Acronym / sponsor ID
- kartalanesthesia
- Conditions
- Postoperative Sore Throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Nov 2023 (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.
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.
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 150 mg (1,5ml) of lidocaine HCl solution 5 minutes before endotracheal intubation, while the second group will receive terile distilled water (1,5ml) 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Lidocaine HydrochlorideFive minutes before endotracheal intubation, 150 mg (1.5 mL) of 10% lidocaine HCl. |
| control group | Placebo comparator | Drug: Drug (Placebo)Five minutes before endotracheal intubation, 1.5 mL sterile distilled water was administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- electively laparoscopic cholecystectomy.
Key exclusion criteria (3 listed)
- ASA IV and above
- lidocaine allergy
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 |
|---|---|---|
| Lidocaine HydrochloridePatients in Group 1 will receive lidocaine HCl solution 5 minutes before endotracheal intubation. | Drug | Lidocaine Group |
| Drug (Placebo)Sterile distilled water (1.5 mL) administration 5 minutes before intubation. | Drug | control group |
Primary outcome
The effect of lidocaine on postoperative sore throat
Time frame: postoperative 24 hours
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).
1 secondary outcome
Effect of lidocaine on hemodynamic response
Time frame: perioperative
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 27 Feb 2026.
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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 Lidocaine Hydrochloride in people with Postoperative Sore Throat, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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 3 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 27 Feb 2026. 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?
The effect of lidocaine on postoperative sore throat (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.