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To Evaluate the Effect of Chlorhexidine-benzidamine Administration

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ClinicalTrials.gov Identifier: NCT03253497
Recruitment Status : Completed
First Posted : August 18, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Savas Altinsoy, 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.


Condition or disease Intervention/treatment Phase
Effects of Topical Chlorhexidine and Benzidine Spray Drug: Chlorobenzene Liquid Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: To Evaluate the Effect of Chlorhexidine-benzidamine Administration Prior to the Use of the Laryngeal Mask
Actual Study Start Date : September 2, 2017
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : December 2, 2017


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



Primary Outcome Measures :
  1. Removal to soft LMA [ Time Frame: First minute after extubation ]
    was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm

  2. complications [ Time Frame: after operation 1th, 6th, 12th and 24th hour ]
    sore throat, ear pain, swallowing difficulty, nausea and vomiting


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • general anesthesia

Exclusion Criteria:

  • using anti-inflammatory drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253497


Locations
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Turkey
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital

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Responsible Party: Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital anestehesia and reanimation, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03253497     History of Changes
Other Study ID Numbers: savaş
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital:
chlorhexidine, benzidamine, laryngeal mask
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Benzydamine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Inflammatory Agents