Tracheal IntubationNCT00908817
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat
A study testing triamcinolone acetonide and chlorhexidine gluconate in people with Tracheal Intubation, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- triamcinolone acetonide and chlorhexidine gluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to May 2009
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- ASA physical status I-II, aged between 20 and 70 years
- scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation
Who cannot join
- recent respiratory tract infection or sore throat
- who were using analgesics or steroid preoperatively
- who have risk factors for oral cavity infection
- the surgical duration < 60 minutes or > 300 minutes
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University, College of medicine Bucheon Hospital
1174 Jung-Dong, Wonmi-Gu, Bucheon-Si, Gyeonggi-do, 420-020
About this study
The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.
Read the detailed description
Sore throat is a common postoperative complaint after tracheal intubation. When the surgical pain is well controlled, sore throat is often the predominant complaint, therefore it is important to prevent sore throat.
- Conditions
- Tracheal Intubation
- Being tested
- triamcinolone acetonide, chlorhexidine gluconate
- Keywords
- postoperative sore throat, tracheal intubation, lubrication, triamcinolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone acetonideDrug
paste applied over tracheal tube for lubrication
chlorhexidine gluconateDrug
jelly applied over tracheal tube for lubrication
| Study group | Role | What they receive |
|---|---|---|
| triamcinolone | Active comparator | Not described Receives: Drug: triamcinolone acetonide |
| chlorhexidine | Placebo comparator | Not described Receives: Drug: chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative sore throat
Measured: postoperative day 1
Secondary outcomes (1)
the severity of postoperative sore throat
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908817
- Sponsor's protocol ID
- ST
- Status last verified
- May 2009
- First submitted
- 21 May 2009
- Last updated
- 27 May 2009
- Results posted
- No
Publications
Park SY, Kim SH, Lee SJ, Chae WS, Jin HC, Lee JS, Kim SI, Hwang KH. Application of triamcinolone acetonide paste to the endotracheal tube reduces postoperative sore throat: a randomized controlled trial. Can J Anaesth. 2011 May;58(5):436-42. doi: 10.1007/s12630-011-9478-6. Epub 2011 Feb 26.
PubMed 21359615
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat
- ClinicalTrials.gov ID
- NCT00908817
- Acronym / sponsor ID
- ST
- Conditions
- Tracheal Intubation
- Keywords
- postoperative sore throat, tracheal intubation, lubrication, triamcinolone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 May 2009 (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.
The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.
Detailed description
Sore throat is a common postoperative complaint after tracheal intubation. When the surgical pain is well controlled, sore throat is often the predominant complaint, therefore it is important to prevent sore throat.
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 |
|---|---|---|
| triamcinolone | Active comparator | Drug: triamcinolone acetonide |
| chlorhexidine | Placebo comparator | Drug: chlorhexidine gluconate |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I-II, aged between 20 and 70 years
- scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation
Key exclusion criteria (4 listed)
- recent respiratory tract infection or sore throat
- who were using analgesics or steroid preoperatively
- who have risk factors for oral cavity infection
- the surgical duration < 60 minutes or > 300 minutes
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 |
|---|---|---|
| triamcinolone acetonidepaste applied over tracheal tube for lubrication | Drug | triamcinolone |
| chlorhexidine gluconatejelly applied over tracheal tube for lubrication | Drug | chlorhexidine |
Primary outcome
the incidence of postoperative sore throat
Time frame: postoperative day 1
1 secondary outcome
the severity of postoperative sore throat
Time frame: postoperative day 1
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 May 2009.
- Derived from this study: PubMed 21359615Park SY, Kim SH, Lee SJ, Chae WS, Jin HC, Lee JS, Kim SI, Hwang KH. Application of triamcinolone acetonide paste to the endotracheal tube reduces postoperative sore throat: a randomized controlled trial. Can J Anaesth. 2011 May;58(5):436-42. doi: 10.1007/s12630-011-9478-6. Epub 2011 Feb 26.
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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 triamcinolone acetonide and chlorhexidine gluconate in people with Tracheal Intubation, run by Soonchunhyang University Hospital at 1 site in South Korea.
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 2 inclusion and 4 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 May 2009. 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 South Korea. 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 incidence of postoperative sore throat (time frame: postoperative day 1). 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 NCT00908817, which also lists 1 linked publication.
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 May 2009.