Sore ThroatPhase 3NCT02114021
Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of
A Phase 3 study testing betamethasone gel, lidocaine jelly and distilled water in people with Sore Throat and Cough, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
ABSTRACT: The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Sore Throat, Cough
- What is being tested?
- betamethasone gel, lidocaine jelly and distilled water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteIran
- Study dates
- Mar 2012to Mar 2013
- Phase
- Phase 3
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 50 years<age>15 years
- no acute upper respiratory infections and no sore throat
- candidate for elective surgery unrelated to the throat
- The lack of airways difficulties
- candidate for general anesthesia with intubation
- no contraindications for receiving steroid
Show all 12Show fewer
- surgery time < 240 minutes
- intubation up to 2 times
- tracheal tube cuff pressure = 25-30 cm H2o
- fasting for 8-6 hours prior to surgery
- ASA I and ASAII and
- Surgery under general anesthesia and endotracheal intubation
Who cannot join
- use of nasogastric tube or throat packs
- patients with upper respiratory tract infection
- patients on steroid therapy were excluded from the study
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Anesthesiology, Booali Hospital, Islamic Azad University,
Tehran
About this study
Official title: Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients
ABSTRACT:
The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran.
Read more
99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients.
For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.
- Conditions
- Sore Throat, Cough
- Being tested
- betamethasone gel, lidocaine jelly, distilled water
- Keywords
- Syndrome incidence after intubation, Betamethasone gel, lidocaine jelly, sore throat, cough, hoarseness of voice
- Medical subject headings
- Pharyngitis, Cough, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
betamethasone gelDrug
betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
lidocaine jellyDrug
the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
distilled waterDrug
The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
| Study group | Role | What they receive |
|---|---|---|
| betamethasone gel | Experimental | betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. Receives: Drug: betamethasone gel; Drug: distilled water |
| lidocaine jelly | Experimental | lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. Receives: Drug: lidocaine jelly; Drug: distilled water |
| distilled water | Placebo comparator | betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sore throat
For the all the patients, the incidence of postoperative cough in 24 hours follow-up based on the different types of medications were obtained (using questionnaire).
Measured: 24 hours after surgery
cough
For the all the patients, the incidence of postoperative cough in 1 hour follow-up periods based on the different types of medications were obtained (using questionnaire).
Measured: 1 hour after surgery
hoarseness of voice
For the all patients, the incidence of postoperative hoarseness of the voice in 1 hour follow-up period based on the different types of medications were obtained (using questionnaire).
Measured: 1 hour after surgery
sore throat
For the all the patients, the incidence of postoperative cough in 1 hour follow up based on the different types of medications were obtained (using questionnaire).
Measured: 1 hour after surgery
sore throat
For the all the patients, the incidence of postoperative cough in 6 hours follow-up based on the different types of medications were obtained (using questionnaire).
Measured: 6 hours after surgery
cough
For the all the patients, the incidence of postoperative cough in 6 hours follow-up periods based on the different types of medications were obtained (using questionnaire).
Measured: 6 hours after surgery
cough
For the all the patients, the incidence of postoperative cough in 24 hours follow-up periods based on the different types of medications were obtained (using questionnaire).
Measured: 24 hours after surgery
hoarseness of voice
For the all patients, the incidence of postoperative hoarseness of the voice in 6 hours follow-up period based on the different types of medications were obtained (using questionnaire).
Measured: 6 hours after surgery
hoarseness of voice
For the all patients, the incidence of postoperative hoarseness of the voice in 24 hours follow-up period based on the different types of medications were obtained (using questionnaire).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Islamic Azad University, Sanandaj
- Responsible party
- Principal investigator, Fatemeh Shahbazi, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114021
- Sponsor's protocol ID
- 08/13/1019
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients
- ClinicalTrials.gov ID
- NCT02114021
- Acronym / sponsor ID
- 08/13/1019
- Conditions
- Sore Throat, Cough
- Keywords
- Syndrome incidence after intubation, Betamethasone gel, lidocaine jelly, sore throat, cough, hoarseness of voice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Islamic Azad University, Sanandaj
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Apr 2014 (estimated)
- 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.
ABSTRACT:
The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran.
99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients.
For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| betamethasone gel | Experimental | Drug: betamethasone gel, Drug: distilled waterbetamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. |
| lidocaine jelly | Experimental | Drug: lidocaine jelly, Drug: distilled waterlidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. |
| distilled water | Placebo comparator | –betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 50 years<age>15 years
- no acute upper respiratory infections and no sore throat
- candidate for elective surgery unrelated to the throat
- The lack of airways difficulties
- candidate for general anesthesia with intubation
Key exclusion criteria (3 listed)
- use of nasogastric tube or throat packs
- patients with upper respiratory tract infection
- patients on steroid therapy were excluded from the study
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 |
|---|---|---|
| betamethasone gelbetamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. | Drug | betamethasone gel |
| lidocaine jellythe effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. | Drug | lidocaine jelly |
| distilled waterThe effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. | Drug | betamethasone gel, lidocaine jelly |
Primary outcome
sore throat
Time frame: 24 hours after surgery
For the all the patients, the incidence of postoperative cough in 24 hours follow-up based on the different types of medications were obtained (using questionnaire).
cough
Time frame: 1 hour after surgery
For the all the patients, the incidence of postoperative cough in 1 hour follow-up periods based on the different types of medications were obtained (using questionnaire).
hoarseness of voice
Time frame: 1 hour after surgery
For the all patients, the incidence of postoperative hoarseness of the voice in 1 hour follow-up period based on the different types of medications were obtained (using questionnaire).
sore throat
Time frame: 1 hour after surgery
For the all the patients, the incidence of postoperative cough in 1 hour follow up based on the different types of medications were obtained (using questionnaire).
sore throat
Time frame: 6 hours after surgery
For the all the patients, the incidence of postoperative cough in 6 hours follow-up based on the different types of medications were obtained (using questionnaire).
cough
Time frame: 6 hours after surgery
For the all the patients, the incidence of postoperative cough in 6 hours follow-up periods based on the different types of medications were obtained (using questionnaire).
cough
Time frame: 24 hours after surgery
For the all the patients, the incidence of postoperative cough in 24 hours follow-up periods based on the different types of medications were obtained (using questionnaire).
hoarseness of voice
Time frame: 6 hours after surgery
For the all patients, the incidence of postoperative hoarseness of the voice in 6 hours follow-up period based on the different types of medications were obtained (using questionnaire).
hoarseness of voice
Time frame: 24 hours after surgery
For the all patients, the incidence of postoperative hoarseness of the voice in 24 hours follow-up period based on the different types of medications were obtained (using questionnaire).
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 15 Apr 2014.
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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 Phase 3 study testing betamethasone gel, lidocaine jelly and distilled water in people with Sore Throat and Cough, run by Tehran University of Medical Sciences at 1 site in Iran.
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 12 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 15 Apr 2014. 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
sore throat (time frame: 24 hours after surgery). The study lists 9 primary outcomes in all. 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 15 Apr 2014.