跳至主要内容
临床试验/NCT03253497
NCT03253497已完成4 期

To Evaluate the Effect of Chlorhexidine-benzidamine Administration Prior to the Use of the Laryngeal Mask

Diskapi Yildirim Beyazit Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Removal to soft LMA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • general anesthesia

排除标准

  • using anti-inflammatory drugs

研究组 & 干预措施

Chlorhexidine- benzidamine

Active Comparator

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

干预措施: Chlorobenzene Liquid (Drug)

结局指标

主要结局

Removal to soft LMA

时间窗: First minute after extubation

was assessed because of coughing, tooth clenching, desaturation, and lack of laryngeal spasm

complications

时间窗: after operation 1th, 6th, 12th and 24th hour

sore throat, ear pain, swallowing difficulty, nausea and vomiting

次要结局

  • Heart rate(before LMA and at 1 minute after LMA applied)
  • hemodynamic response(before LMA and at 1 minute after LMA applied)

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Savas Altinsoy

Diskapi Yildirim Beyazit Education and Research Hospital anestehesia and reanimation

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (1)

Loading locations...

相似试验

To Evaluate the Effect of Chlorhexidine-benzidamine... | 临床试验