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To Evaluate the Effect of Chlorhexidine-benzidamine Administration

NCT ID: NCT03253497

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-02

Study Completion Date

2017-12-02

Brief Summary

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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

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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.

Conditions

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Effects of Topical Chlorhexidine and Benzidine Spray

Keywords

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chlorhexidine, benzidamine, laryngeal mask

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chlorhexidine- benzidamine

before 15 minute anesthesia induction Chlorhexidine-benzidamine spray will be administrated to oropharynx

Group Type ACTIVE_COMPARATOR

Chlorobenzene Liquid

Intervention Type DRUG

before induction will be used for oropharynx

Control

before 15 minute normal salin will be administrated to oropharynx

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chlorobenzene Liquid

before induction will be used for oropharynx

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* general anesthesia

Exclusion Criteria

* using anti-inflammatory drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Savas Altinsoy

Diskapi Yildirim Beyazit Education and Research Hospital anestehesia and reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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savaş

Identifier Type: -

Identifier Source: org_study_id