- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253497
To Evaluate the Effect of Chlorhexidine-benzidamine Administration
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
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- general anesthesia
Exclusion Criteria:
- using anti-inflammatory drugs
Study Plan
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
|
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- savaş
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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