To Evaluate the Effect of Chlorhexidine-benzidamine Administration

December 22, 2017 updated by: Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • general anesthesia

Exclusion Criteria:

  • using anti-inflammatory drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Chlorhexidine- benzidamine
before 15 minute anesthesia induction Chlorhexidine-benzidamine spray will be administrated to oropharynx
Drug: Chlorobenzene Liquid
before induction will be used for oropharynx
NO_INTERVENTION: Control
before 15 minute normal salin will be administrated to oropharynx

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic response
Time Frame: 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.
before LMA and at 1 minute after LMA applied
Heart rate
Time Frame: before LMA and at 1 minute after LMA applied
Heart rate will record before LMA insertion and post LMA used at first minute.
before LMA and at 1 minute after LMA applied

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 2, 2017

Primary Completion (ACTUAL)

October 2, 2017

Study Completion (ACTUAL)

December 2, 2017

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (ACTUAL)

August 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • savaş

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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