Sore ThroatNCT03779516
Effect of Nebulized Lidocaine on Postoperative Sore Throat
A study testing Saline and Lidocaine in people with Sore Throat, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sore Throat
- What is being tested?
- Saline and Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2018to 15 Jul 2019
- 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
- patients undergoing video-assisted thoracic surgery requiring double lumen tube endotracheal intubation for one-lung ventilation
- American Society of Anesthesiologists class 1,2 and 3
- Ability to consent
Who cannot join
- patients <18 years old
- body mass index (BMI) <20 or >35 kg/m2
- Mallampati grade 3 or 4
- mouth opening < 3 cm
- preexisting hoarseness or sore throat
- coagulopathy
- patient with upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation
The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation.
Read the detailed description
Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study. Patients were randomized by means of computer-generated order randomization into two groups: Group C (those who received a saline solution as placebo delivered by nebulization) and Group L (those who received lidocaine delivered by nebulization).
At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction, intraoperative and postoperative opioid and analgesics consumption and complaints such as dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure and heart rate were also recorded.
- Conditions
- Sore Throat
- Being tested
- Saline, Lidocaine
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
Effect of saline on postoperative sore throat
LidocaineOther
Effect of nebulized lidocaine on postoperative sore throat
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min Receives: Other: Saline |
| Group L | Active comparator | In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min Receives: Other: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the incidence of postoperative sore throat
Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.
Measured: 24 hours
Secondary outcomes (5)
whether the hoarseness was present or not
Hoarseness was defined as a change in voice quality and it was assessed by the patients themselves. The change in voice quality at any time during the observation period was defined as "hoarseness was present".
Measured: 24 hours
Intraoperative opioid consumption
Assessed in intraoperative period
Measured: 60 minutes
Postoperative analgesic consumption
Assessed in postoperative period
Measured: 24 hours
Changes in mean arterial pressure
Assessed every 5 minutes during the procedure
Measured: 60 minutes
Changes in heart rate
Assessed every 5 minutes during the procedure
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start19 Dec 2018
- Primary completion22 Apr 2019
- Study completion15 Jul 2019
Why it stopped: change in procedure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ali Sait Kavakli, MD, Principal investigator, Antalya Training and Research HospitalHilal Yavuzel, MD, Principal investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalUlku Arslan, MD, Principal investigator, Karabuk University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779516
- Sponsor's protocol ID
- AntalyaTRH 28
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT03779516
- Acronym / sponsor ID
- AntalyaTRH 28
- Conditions
- Sore Throat
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in procedure
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 19 Dec 2018 (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.
The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation.
Detailed description
Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study. Patients were randomized by means of computer-generated order randomization into two groups: Group C (those who received a saline solution as placebo delivered by nebulization) and Group L (those who received lidocaine delivered by nebulization).
At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction, intraoperative and postoperative opioid and analgesics consumption and complaints such as dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure and heart rate were also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Other: SalineIn Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min |
| Group L | Active comparator | Other: LidocaineIn Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing video-assisted thoracic surgery requiring double lumen tube endotracheal intubation for one-lung ventilation
- American Society of Anesthesiologists class 1,2 and 3
- Ability to consent
Key exclusion criteria (7 listed)
- patients <18 years old
- body mass index (BMI) <20 or >35 kg/m2
- Mallampati grade 3 or 4
- mouth opening < 3 cm
- preexisting hoarseness or sore throat
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 |
|---|---|---|
| SalineEffect of saline on postoperative sore throat | Other | Group C |
| LidocaineEffect of nebulized lidocaine on postoperative sore throat | Other | Group L |
Primary outcome
Changes in the incidence of postoperative sore throat
Time frame: 24 hours
Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.
5 secondary outcomes
whether the hoarseness was present or not
Time frame: 24 hours
Intraoperative opioid consumption
Time frame: 60 minutes
Postoperative analgesic consumption
Time frame: 24 hours
Changes in mean arterial pressure
Time frame: 60 minutes
Changes in heart rate
Time frame: 60 minutes
Results and safety
The study was stopped early (reason given: change in procedure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
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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.
Ali Sait Kavakli, MD principal investigator
Antalya Training and Research Hospital
Hilal Yavuzel, MD principal investigator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Ulku Arslan, MD principal investigator
Karabuk University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline and Lidocaine in people with Sore Throat, run by Antalya 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 7 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: stopped early, as of the sponsor's last update on 30 Apr 2020. 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. 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 was stopped early (reason given: change in procedure). Results are not available in the source record.
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?
Changes in the incidence of postoperative sore throat (time frame: 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 30 Apr 2020.