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To Evaluate the Effect of Chlorhexidine-benzidamine Administration

To Evaluate the Effect of Chlorhexidine-benzidamine Administration Prior to the Use of the Laryngeal Mask

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03253497
Enrollment
50
Registered
2017-08-18
Start date
2017-09-02
Completion date
2017-12-02
Last updated
2017-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of Topical Chlorhexidine and Benzidine Spray

Keywords

chlorhexidine, benzidamine, laryngeal mask

Brief 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 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.

Interventions

DRUGChlorobenzene Liquid

before induction will be used for oropharynx

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* general anesthesia

Exclusion criteria

* using anti-inflammatory drugs

Design outcomes

Primary

MeasureTime frameDescription
Removal to soft LMAFirst minute after extubationwas assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm
complicationsafter operation 1th, 6th, 12th and 24th hoursore throat, ear pain, swallowing difficulty, nausea and vomiting

Secondary

MeasureTime frameDescription
hemodynamic responsebefore LMA and at 1 minute after LMA appliedsystolic, diastolic and mean blood pressure will record before LMA and post LMA used at first minute.
Heart ratebefore LMA and at 1 minute after LMA appliedHeart rate will record before LMA insertion and post LMA used at first minute.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026