Effects of Topical Chlorhexidine and Benzidine Spray Clinical Trial
Official title:
To Evaluate the Effect of Chlorhexidine-benzidamine Administration Prior to the Use of the Laryngeal Mask
| Verified date | December 2017 |
| Source | Diskapi Yildirim Beyazit Education and Research Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 2, 2017 |
| Est. primary completion date | October 2, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - general anesthesia Exclusion Criteria: - using anti-inflammatory drugs |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Diskapi Yildirim Beyazit Education and Research Hospital |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Removal to soft LMA | was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm | First minute after extubation | |
| Primary | complications | sore throat, ear pain, swallowing difficulty, nausea and vomiting | after operation 1th, 6th, 12th and 24th hour | |
| Secondary | hemodynamic response | systolic, diastolic and mean blood pressure will record before LMA and post LMA used at first minute. | before LMA and at 1 minute after LMA applied | |
| Secondary | Heart rate | Heart rate will record before LMA insertion and post LMA used at first minute. | before LMA and at 1 minute after LMA applied |