Effects of Topical Chlorhexidine and Benzidine SprayPhase 4NCT03253497
To Evaluate the Effect of Chlorhexidine-benzidamine Administration
A Phase 4 study testing Chlorobenzene Liquid in people with Effects of Topical Chlorhexidine and Benzidine Spray, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The use of laryngeal mask (LMA) for the purpose of providing airway safety of patients is a common method in general anesthesia practice. This practice does not require laryngoscopy and there is no laryngeal and tracheal stimulation until endotracheal intubation, so an increased hemodynamic response is not expected in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Effects of Topical Chlorhexidine and Benzidine Spray
- What is being tested?
- Chlorobenzene Liquid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2017to 2 Dec 2017
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- general anesthesia
Who cannot join
- using anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
Ankara
About this study
Official title: To Evaluate the Effect of Chlorhexidine-benzidamine Administration Prior to the Use of the Laryngeal Mask
The use of laryngeal mask (LMA) for the purpose of providing airway safety of patients is a common method in general anesthesia practice. This practice does not require laryngoscopy and there is no laryngeal and tracheal stimulation until endotracheal intubation, so an increased hemodynamic response is not expected in the patient. LMA is an airway control device consisting of a silicon mask commonly used in cases where endotracheal intubation (ETE) is not required and a silicone tubing connected by 30 degrees. The glottic settles around the entrance. There is no obligation for muscle relaxation as LMA is intubated. However, if a muscle relaxant agent is not used, pharyngolaryngeal side effects such as patient wounds, hiccups, coughs, involuntary muscle movement, hypoxia, laryngospasm can be seen when LMA is inserted. In these patients complications such as throat burning, sore throat, ear pain, voice anxiety, swallowing difficulties are seen depending on the difficulty of LMA placement in the postoperative period.
Benzidamine is an anti-inflammatory analgesic agent that is not related to the steroid group as the structure. Benzidamine is different from other non-steroidal anti-inflammatory agents in terms of base formation. Benzidamine has local anesthetic effect in concentrations used in topical treatment. Chlorhexidine grams (+) gram (-) bacteria are most effective in microorganisms such as yeast and some fungi and viruses. Chlorhexidine delays bacterial spread with delayed surface effect. It is absorptive from the microbial cell walls and causes membrane leakage.
In this study, investigators aimed to reveal the effects of topical chlorhexidine and benzidamine containing spray (chlorobenzene 30 Ml Spray) used before LMA placement on hemodynamic response with postoperative throat and ear pain, swallowing difficulty, voice anxiety and soft LMA removal.
Read the detailed description
50 participants with American Society of Anesthesiologists (ASA) physical score I-II. laryngeal mask (LMA) will use in general anesthesia.
all participants will be premedicated with 0.05 mg/kg midazolam 30 minutes before the operation. ASA, age, sex, body mass index (BMI) will record. peripheral oxygen saturation (SaO2) ,electrocardiography and non invasive blood pressure will monitored. A venous cannula will place on the back of the hand. participants will randomly divide into 2 groups by closed envelope method.
before 15 minute anesthesia induction topical chlorobenzene 30 Ml Spray will use. Than LMA will placement on and record hemodynamic response and postoperative throat and ear pain, swallowing difficulty, voice anxiety and soft LMA removal.
- Being tested
- Chlorobenzene Liquid
- Keywords
- chlorhexidine, benzidamine, laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorobenzene LiquidDrug
before induction will be used for oropharynx
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine- benzidamine | Active comparator | before 15 minute anesthesia induction Chlorhexidine-benzidamine spray will be administrated to oropharynx Receives: Drug: Chlorobenzene Liquid |
| Control | No intervention | before 15 minute normal salin will be administrated to oropharynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal to soft LMA
was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm
Measured: First minute after extubation
complications
sore throat, ear pain, swallowing difficulty, nausea and vomiting
Measured: after operation 1th, 6th, 12th and 24th hour
Secondary outcomes (2)
hemodynamic response
systolic, diastolic and mean blood pressure will record before LMA and post LMA used at first minute.
Measured: before LMA and at 1 minute after LMA applied
Heart rate
Heart rate will record before LMA insertion and post LMA used at first minute.
Measured: before LMA and at 1 minute after LMA applied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start2 Sep 2017
- Primary completion2 Oct 2017
- Study completion2 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Topical Chlorhexidine and Benzidine SprayStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253497
- Sponsor's protocol ID
- savaş
- Status last verified
- Dec 2017
- First submitted
- 11 Aug 2017
- Last updated
- 27 Dec 2017
- 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 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of Chlorhexidine-benzidamine Administration Prior to the Use of the Laryngeal Mask
- ClinicalTrials.gov ID
- NCT03253497
- Acronym / sponsor ID
- savaş
- Keywords
- chlorhexidine, benzidamine, laryngeal mask
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 2 Sep 2017 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Dec 2017 (actual)
- First posted
- 18 Aug 2017 (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 use of laryngeal mask (LMA) for the purpose of providing airway safety of patients is a common method in general anesthesia practice. This practice does not require laryngoscopy and there is no laryngeal and tracheal stimulation until endotracheal intubation, so an increased hemodynamic response is not expected in the patient. LMA is an airway control device consisting of a silicon mask commonly used in cases where endotracheal intubation (ETE) is not required and a silicone tubing connected by 30 degrees. The glottic settles around the entrance. There is no obligation for muscle relaxation as LMA is intubated. However, if a muscle relaxant agent is not used, pharyngolaryngeal side effects such as patient wounds, hiccups, coughs, involuntary muscle movement, hypoxia, laryngospasm can be seen when LMA is inserted. In these patients complications such as throat burning, sore throat, ear pain, voice anxiety, swallowing difficulties are seen depending on the difficulty of LMA placement in the postoperative period.
Benzidamine is an anti-inflammatory analgesic agent that is not related to the steroid group as the structure. Benzidamine is different from other non-steroidal anti-inflammatory agents in terms of base formation. Benzidamine has local anesthetic effect in concentrations used in topical treatment. Chlorhexidine grams (+) gram (-) bacteria are most effective in microorganisms such as yeast and some fungi and viruses. Chlorhexidine delays bacterial spread with delayed surface effect. It is absorptive from the microbial cell walls and causes membrane leakage.
In this study, investigators aimed to reveal the effects of topical chlorhexidine and benzidamine containing spray (chlorobenzene 30 Ml Spray) used before LMA placement on hemodynamic response with postoperative throat and ear pain, swallowing difficulty, voice anxiety and soft LMA removal.
Detailed description
50 participants with American Society of Anesthesiologists (ASA) physical score I-II. laryngeal mask (LMA) will use in general anesthesia.
all participants will be premedicated with 0.05 mg/kg midazolam 30 minutes before the operation. ASA, age, sex, body mass index (BMI) will record. peripheral oxygen saturation (SaO2) ,electrocardiography and non invasive blood pressure will monitored. A venous cannula will place on the back of the hand. participants will randomly divide into 2 groups by closed envelope method.
before 15 minute anesthesia induction topical chlorobenzene 30 Ml Spray will use. Than LMA will placement on and record hemodynamic response and postoperative throat and ear pain, swallowing difficulty, voice anxiety and soft LMA removal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine- benzidamine | Active comparator | Drug: Chlorobenzene Liquidbefore 15 minute anesthesia induction Chlorhexidine-benzidamine spray will be administrated to oropharynx |
| Control | No intervention | –before 15 minute normal salin will be administrated to oropharynx |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- general anesthesia
Key exclusion criteria (1 listed)
- using anti-inflammatory drugs
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 |
|---|---|---|
| Chlorobenzene Liquidbefore induction will be used for oropharynx | Drug | Chlorhexidine- benzidamine |
Primary outcome
Removal to soft LMA
Time frame: First minute after extubation
was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm
complications
Time frame: after operation 1th, 6th, 12th and 24th hour
sore throat, ear pain, swallowing difficulty, nausea and vomiting
2 secondary outcomes
hemodynamic response
Time frame: before LMA and at 1 minute after LMA applied
Heart rate
Time frame: before LMA and at 1 minute after LMA applied
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 Dec 2017.
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 4 study testing Chlorobenzene Liquid in people with Effects of Topical Chlorhexidine and Benzidine Spray, run by Diskapi Yildirim Beyazit Education 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 1 inclusion and 1 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 Dec 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Removal to soft LMA (time frame: First minute after extubation). The study lists 2 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 27 Dec 2017.