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临床试验/CTRI/2025/07/090189
CTRI/2025/07/090189尚未招募不适用

Effectiveness Of 5 percentage EMLA Cream in reducing Post Operative Sore Throat in adults undergoing General Anaesthesia A prospective observational study

Sandhiya M N1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
To evaluate the effect of Percentage EMLA Cream in reducing the incidence and severity of postoperative sore throat in adult patient after general anaesthesia.

研究概览

简要总结

Title:Effectiveness Of 5% EMLA Cream in reducing Post Operative Sore Throat in adults undergoing General Anaesthesia - A prospective observational study

The patients who meet the inclusion criteria will be selected for this study. After obtaining approval from the ethical committee, the data will be collected. The basic parameters are collected from the patient and Mallampati and Cormack lehane grading will be assessed. Mallampati grading is a clinical assessment used to evaluate the visibility of structures in the mouth and throat to help predict the difficulty of intubation. CLASS I (full visibility of all structures), CLASS 2(Soft palate, fauces, and uvula visible), CLASS 3(Soft palate and base of uvula visible), CLASS 4(Only hard palate visible; soft palate not visible). Cormack-Lehane grading is a system used to describe the view of the larynx during direct laryngoscopy, primarily to assess the difficulty of intubation. Grade I: Full view of the glottis (vocal cords visible). Grade II: Partial view of the glottis (only posterior part visible). Grade III: Only epiglottis visible; no part of the glottis seen. Grade IV: Neither glottis nor epiglottis visible. It will be performed each time by simple random sampling method by using a computerized randomizing software.Once the patient is shifted to operation theatre. An expert anaesthesiologist with at least 3 years of experience will perform direct mild laryngoscopy and intubation within 15 seconds. Lubricating ETT with 5% EMLA Cream. After surgery, the patient will be transferred to the post-operative unit and monitored for POST at 4th, 6th, and 24th hours to assess its severity. POST refers to symptoms such as throat soreness, coughing, and hoarseness within 24 hours Post surgery. [3] POST intensity will be classified into four levels: none (grade 0), mild (grade 1-Less than a common cold), moderate (grade 2-Similar to a common cold), and severe (grade 3-More than a common cold)  Grade 2 and 3 POST was considered as significant POST. Cough severity will be categorized as NO COUGH (0-no cough at any time since the operation), MILD (1-mild cough or occasional cough), MODERATE (2-similar to a common cold), and SEVERE (3-more than a common cold ). Hoarseness of voice will be classified as NO HOARSENESS (0-no evidence of hoarseness at any time after operation), MINIMAL (1-no hoarseness at the time of interview but was present previously), MODERATE (2-moderate change in quality of speech ), or SEVERE (3-recognizable at the time of interview)12. Visual analog scale is used to assess the patient satisfaction/comfort and pain. Patients will be monitored for any potential adverse effects, including allergic responses. Participants in the study who experience post-operative sore throat despite using 5% EMLA cream will be treated according to department and hospital protocols.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patient of aged 19 to 65 years ASA 1 and 2 scheduled for Elective surgeries Electives surgeries – ENT, Laparoscopic surgeries, oncology surgeries and the surgeries which required general anaesthesia Duration of surgeries 4 to 6 hours under general with endotracheal anaesthesia.

排除标准

  • Allergy to local anaesthetics More than 2 intubation attempts Assisted nasogastric tube inserted or the use of throat pack The instrumentation which involve upper airway surgeries Pre-operative sore throat Difficult airway Surgeries in prone position.

结局指标

主要结局

To evaluate the effect of Percentage EMLA Cream in reducing the incidence and severity of postoperative sore throat in adult patient after general anaesthesia.

时间窗: Incidence and severity of postoperative sore throat and Hoarseness will be assessed by using a grade at four time points(after 1 hour, after 6,after 12 hours and after 24hours postoperatively) [5-6min]

次要结局

  • To determine patient satisfaction comfort levels associated with the use of EMLA Cream for postoperative sore throat prevention(Satisfaction comfort levels of the patients will be assessed in postoperative room after 1hour of the surgery)

研究者

发起方
Sandhiya M N
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sandhiya M N

Yenepoya school of allied health sciences

研究点 (1)

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