To Evaluate the Effect of Chlorhexidine-benzidamine Administration

Phase 4

Completed

• Conditions: Effects of Topical Chlorhexidine and Benzidine Spray
• Interventions: Drug: Chlorobenzene Liquid

• Registration Number: NCT03253497
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-15
• Study First Posted: 2017-08-18
• Study Start: 2017-09-02
• Primary Completion: 2017-10-02
• Status Verified: 2017-12
• Study Completion: 2017-12-02
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• general anesthesia

Exclusion Criteria

• using anti-inflammatory drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chlorhexidine- benzidamine	Chlorobenzene Liquid	before 15 minute anesthesia induction Chlorhexidine-benzidamine spray will be administrated to oropharynx

Primary Outcome Measures

Name	Time	Method
Removal to soft LMA	First minute after extubation	was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm
complications	after operation 1th, 6th, 12th and 24th hour	sore throat, ear pain, swallowing difficulty, nausea and vomiting

Secondary Outcome Measures

Name	Time	Method
Heart rate	before LMA and at 1 minute after LMA applied	Heart rate will record before LMA insertion and post LMA used at first minute.
hemodynamic response	before LMA and at 1 minute after LMA applied	systolic, diastolic and mean blood pressure will record before LMA and post LMA used at first minute.

Trial Locations

Locations (1)

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital; 🇹🇷 Ankara, Turkey